{ "fetched": "2026-07-16", "codes": { "OHS": { "total": 155, "records": [ { "k_number": "K261473", "device_name": "Chromix", "applicant": "Termosalud S.L.", "decision_date": "2026-07-01", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Gijon", "country_code": "ES" }, { "k_number": "K261052", "device_name": "LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)", "applicant": "Guangdong Newdermo Biotech Co., Ltd.", "decision_date": "2026-06-29", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangzhou", "country_code": "CN" }, { "k_number": "K260946", "device_name": "LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)", "applicant": "Guangdong Newdermo Biotech Co., Ltd.", "decision_date": "2026-06-18", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangzhou", "country_code": "CN" }, { "k_number": "K254025", "device_name": "LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2026-06-16", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K260715", "device_name": "CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)", "applicant": "The Beauty Tech Group, Ltd.", "decision_date": "2026-06-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Macclesfield", "country_code": "GB" }, { "k_number": "K260415", "device_name": "myLEDmask 2 (MJ-144)", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2026-05-12", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Den Haag", "country_code": "NL" }, { "k_number": "K260150", "device_name": "LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)", "applicant": "NOOANCE", "decision_date": "2026-04-22", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Paris", "country_code": "FR" }, { "k_number": "K260202", "device_name": "LED Light Therapy Masks (LumiLips FAC07NA)", "applicant": "Guangdong Newdermo Biotech Co., Ltd.", "decision_date": "2026-03-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangzhou", "country_code": "CN" }, { "k_number": "K260511", "device_name": "Ulike Reglow Light Therapy Device (UM10)", "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.", "decision_date": "2026-03-16", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K254079", "device_name": "LED Light Therapy Mask (Models: T2, RLD10)", "applicant": "Shenzhen Desida Technology Co., Ltd.", "decision_date": "2026-03-16", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253874", "device_name": "LED Therapy Light (COB1400, HP1800PRO)", "applicant": "Shenzhen Hanhua Opto Co., Ltd.", "decision_date": "2026-03-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253683", "device_name": "FAQ™ (LED Panel); FAQ™ (Dual LED Panel)", "applicant": "Foreo, Inc.", "decision_date": "2026-02-20", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Statement", "city": "Las Vegas", "country_code": "US" }, { "k_number": "K254007", "device_name": "LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)", "applicant": "SZ KKS Silicone&Electronic Co., Ltd.", "decision_date": "2026-02-12", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253833", "device_name": "Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)", "applicant": "Shenzhen Jianchao Intelligent Technology Co., Ltd.", "decision_date": "2026-01-30", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252603", "device_name": "HIGHERDOSE Body Sculptor (Model: GS-03)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2026-01-28", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253712", "device_name": "LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)", "applicant": "Shenzhen Rainbow Technology Co., Ltd.", "decision_date": "2026-01-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253279", "device_name": "Feather/numiere 05 06 07 (05)", "applicant": "Heat IN A Click, LLC", "decision_date": "2025-12-24", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dania", "country_code": "US" }, { "k_number": "K253400", "device_name": "LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)", "applicant": "Shenzhen Saidi Light Therapy Technology Co., Ltd.", "decision_date": "2025-12-24", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253135", "device_name": "LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)", "applicant": "Dongguan Yijiaming Technology Co., Ltd.", "decision_date": "2025-12-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan", "country_code": "CN" }, { "k_number": "K253054", "device_name": "LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)", "applicant": "Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.", "decision_date": "2025-12-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253086", "device_name": "LED Light Therapy Device (Models: SG-FM, SG-FE)", "applicant": "Sunglor Technology Co., Ltd.", "decision_date": "2025-12-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252983", "device_name": "Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)", "applicant": "Shenzhen Goodwind Technology Development Co., Ltd.", "decision_date": "2025-12-17", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252994", "device_name": "LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)", "applicant": "Guangdong Ace-Tec Co., Ltd.", "decision_date": "2025-12-08", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan", "country_code": "CN" }, { "k_number": "K252142", "device_name": "Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)", "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.", "decision_date": "2025-12-05", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252642", "device_name": "Microcurrent Facial Device (CEC101, EEI101)", "applicant": "Shenzhen Dachi Communication Co., Ltd.", "decision_date": "2025-11-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K253073", "device_name": "LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)", "applicant": "Sunglor Technology Co., Ltd.", "decision_date": "2025-11-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252308", "device_name": "LED Beauty Mask (RLBXX)", "applicant": "Atop Lighting Co., Ltd.", "decision_date": "2025-11-13", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen City", "country_code": "CN" }, { "k_number": "K252053", "device_name": "VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)", "applicant": "Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd", "decision_date": "2025-10-27", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252264", "device_name": "MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)", "applicant": "Shenzhen Zhenxing Ruitong Technology Co., Ltd.", "decision_date": "2025-10-17", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252093", "device_name": "Light Therapy Mask (1019055)", "applicant": "Merchsource, LLC", "decision_date": "2025-10-16", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K252272", "device_name": "ORA Method LED Gua Sha (GS-04)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-10-09", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252096", "device_name": "Light Therapy Decollete Mask (1019135)", "applicant": "Merchsource, LLC", "decision_date": "2025-10-01", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K251825", "device_name": "Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)", "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.", "decision_date": "2025-10-01", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K252189", "device_name": "LED Light Therapy Mask (2311, 2344, 2457, 2458)", "applicant": "Dongguan Yanxi Technology Co., Ltd.", "decision_date": "2025-09-12", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan", "country_code": "CN" }, { "k_number": "K251781", "device_name": "KALA MINI 2.0 (KALA-04)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-09-04", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K251588", "device_name": "LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)", "applicant": "Shenzhen Fittop Health Technology Co., Ltd.", "decision_date": "2025-08-21", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K251871", "device_name": "FEATHER 01 02 03 04 (Model:01)", "applicant": "Heat IN A Click, LLC", "decision_date": "2025-08-15", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dania", "country_code": "US" }, { "k_number": "K251012", "device_name": "TRUDERMAL Pro (ZLD-390)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-08-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K251667", "device_name": "LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)", "applicant": "Shenzhen Liyoutong Technology Co., Ltd.", "decision_date": "2025-08-07", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K250761", "device_name": "KALA Therapy Wand (Model: KALA-03)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-07-11", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K250966", "device_name": "CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-06-25", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K250880", "device_name": "LED LIGHT MASK (A093)", "applicant": "Foshan Guangyu Weilai Medical Equipment Co., Ltd.", "decision_date": "2025-06-20", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Foshan", "country_code": "CN" }, { "k_number": "K243978", "device_name": "LED Facial Mask", "applicant": "Shenzhen Sunsred Technology Co.,Ltd", "decision_date": "2025-06-20", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K250830", "device_name": "LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)", "applicant": "Shenzhen Sungrow Led Technology Co., Ltd.", "decision_date": "2025-06-09", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K251042", "device_name": "Light Therapy System (M500, L6)", "applicant": "Guangzhou Ahead Intelligent Technology Co., Ltd.", "decision_date": "2025-06-06", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangzhou", "country_code": "CN" }, { "k_number": "K250581", "device_name": "KALA Red Light Face Mask (KALA-01)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-05-30", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K250532", "device_name": "Solawave 2-in-1 Skincare Mini (Model: 61043)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-05-22", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K244020", "device_name": "Wrinkle Treatment Device (JM1, JM2B)", "applicant": "Shenzhen Qianyu Technology Co., Ltd.", "decision_date": "2025-05-01", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K242151", "device_name": "Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)", "applicant": "Shenzhen Nuon Medical Equipment Co., Ltd.", "decision_date": "2025-04-08", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K242385", "device_name": "LED Therapy Mask (MN1, M226)", "applicant": "Shenzhen Borria Technology Co., Ltd.", "decision_date": "2025-04-07", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K250125", "device_name": "LMNT O2", "applicant": "Xplr , Ltd.", "decision_date": "2025-03-24", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Ben Ami 6 St", "country_code": "IL" }, { "k_number": "K250413", "device_name": "Aglaia LED Beauty Device (BP-D2309)", "applicant": "Shenzhen Perfect Idea Technology Limited", "decision_date": "2025-03-18", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Statement", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K241947", "device_name": "EnergyLounger (TY-01)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-03-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K243330", "device_name": "LYMA Laser PRO", "applicant": "Lyma Life , Ltd.", "decision_date": "2025-02-21", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "London", "country_code": "GB" }, { "k_number": "K242593", "device_name": "CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2025-02-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K243423", "device_name": "LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)", "applicant": "Shenzhen Rainbow Technology Co., Ltd.", "decision_date": "2025-01-28", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K243492", "device_name": "Ulike Reglow Light Therapy Device (UM10)", "applicant": "Shenzhen Ulike Smart Electronics Co., Ltd.", "decision_date": "2025-01-10", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K242789", "device_name": "Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)", "applicant": "Dongguan Laiguang Electronic Technology Co., Ltd.", "decision_date": "2025-01-02", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan", "country_code": "CN" }, { "k_number": "K243040", "device_name": "LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)", "applicant": "Shenzhen Siken 3D Technology Development Co., Ltd.", "decision_date": "2024-12-20", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K242700", "device_name": "Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)", "applicant": "Shenzhen Nuon Medical Equipment Co., Ltd.", "decision_date": "2024-12-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K242796", "device_name": "CryoGlow (FW3XXXX)", "applicant": "Sharkninja Operating, LLC", "decision_date": "2024-11-27", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Needham", "country_code": "US" }, { "k_number": "K242638", "device_name": "LED Light Therapy Machine (G1, G3, G4, G6)", "applicant": "Shenzhen Walton Technology Co., Ltd.", "decision_date": "2024-11-27", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen City", "country_code": "CN" }, { "k_number": "K242382", "device_name": "décoLITE LED Device", "applicant": "iSMART Developments, Ltd.", "decision_date": "2024-11-08", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Birmingham", "country_code": "GB" }, { "k_number": "K241718", "device_name": "Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)", "applicant": "Shenzhen Aozemei Technology Co., Ltd.", "decision_date": "2024-10-28", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K241857", "device_name": "LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)", "applicant": "Dongguan Boyuan Intelligent Technology Co.,Ltd", "decision_date": "2024-10-11", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan", "country_code": "CN" }, { "k_number": "K241933", "device_name": "HIGHERDOSE Red and Infrared Light Mask (MK66-L)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2024-09-27", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K241102", "device_name": "Luna 4 plus", "applicant": "Foreo, Inc.", "decision_date": "2024-08-20", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Las Vegas", "country_code": "US" }, { "k_number": "K241203", "device_name": "PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)", "applicant": "Dongguan Hunter Electronic Technology Co., Ltd.", "decision_date": "2024-07-25", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangdong", "country_code": "CN" }, { "k_number": "K240378", "device_name": "FAQ™ 201, FAQ™ 202", "applicant": "Foreo, Inc.", "decision_date": "2024-04-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Statement", "city": "Las Vegas", "country_code": "US" }, { "k_number": "K240089", "device_name": "Face Patches (MT-12MA, MT-12MC)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2024-04-10", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K240360", "device_name": "Wrinkle Treatment Device (JM2)", "applicant": "Shenzhen Qianyu Technology Co., Ltd.", "decision_date": "2024-04-05", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen City", "country_code": "CN" }, { "k_number": "K233862", "device_name": "NUNA LUX (NUNL528)", "applicant": "Premier North America, Inc.", "decision_date": "2024-03-01", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Lauderdale", "country_code": "US" }, { "k_number": "K233114", "device_name": "LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)", "applicant": "Shenzhen Idea Light Limited", "decision_date": "2024-01-12", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K233556", "device_name": "LED Eye mask (EY-20R, A20, EY-20N)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2024-01-04", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K232863", "device_name": "Radiant Renewal Skincare Wand (HD-15, HD-15A)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2023-12-13", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K232795", "device_name": "Led Mask Platinum Exclusive MD", "applicant": "Stg24 Co., Ltd.", "decision_date": "2023-12-07", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Incheon", "country_code": "KR" }, { "k_number": "K223919", "device_name": "B.Light Clear Evo and B.Light Restore Evo", "applicant": "Bemer Int AG", "decision_date": "2023-09-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Triesen", "country_code": "LI" }, { "k_number": "K231555", "device_name": "LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))", "applicant": "iSMART Developments, Ltd.", "decision_date": "2023-07-27", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Birmingham", "country_code": "GB" }, { "k_number": "K230293", "device_name": "TheraFace Mask", "applicant": "Therabody, Inc.", "decision_date": "2023-06-09", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Los Angeles", "country_code": "US" }, { "k_number": "K223893", "device_name": "Infrared Heat (Model: E0221)", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2023-05-16", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hague", "country_code": "NL" }, { "k_number": "K223147", "device_name": "myLEDmask", "applicant": "Myblend", "decision_date": "2023-05-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Neuilly-Sur-Seine", "country_code": "FR" }, { "k_number": "K230351", "device_name": "LED Facial Mask", "applicant": "Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.", "decision_date": "2023-05-05", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K230042", "device_name": "Q-Rejuvalight Pro Facewear (Model: P19-0023)", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2023-04-28", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hague", "country_code": "NL" }, { "k_number": "K230124", "device_name": "LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2023-03-15", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hague", "country_code": "NL" }, { "k_number": "K223544", "device_name": "LED light therapy mask (FM-01, FM-02, FM-03)", "applicant": "Guangdong Newdermo Biotech Co., Ltd.", "decision_date": "2023-02-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangzhou", "country_code": "CN" }, { "k_number": "K222685", "device_name": "NIRA Model 2", "applicant": "Dermal Photonics Corp", "decision_date": "2023-02-08", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Danvers", "country_code": "US" }, { "k_number": "K223482", "device_name": "reVive Light Therapy® Wrinkle and Acne LED Device", "applicant": "Led Technologies, Inc.", "decision_date": "2022-12-21", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Largo", "country_code": "US" }, { "k_number": "K221775", "device_name": "LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2022-12-20", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Den Haag", "country_code": "NL" }, { "k_number": "K221444", "device_name": "LED Eye Perfector, model: EY-36A, EY-36B", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2022-12-08", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Den Haag", "country_code": "NL" }, { "k_number": "K221946", "device_name": "LED Light Therapy Mask (model: MK66R-B)", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2022-11-22", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Den Haag", "country_code": "NL" }, { "k_number": "K223278", "device_name": "easy Claire", "applicant": "Y & J Bio Co., Ltd.", "decision_date": "2022-11-17", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Hanam-Si", "country_code": "KR" }, { "k_number": "K222377", "device_name": "Led Mask Platinum Md", "applicant": "Cellreturn Co., Ltd.", "decision_date": "2022-11-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Incheon", "country_code": "KR" }, { "k_number": "K221430", "device_name": "reVive Light Therapy LED Cleansing System", "applicant": "Led Technologies, Inc.", "decision_date": "2022-07-27", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Largo", "country_code": "US" }, { "k_number": "K220064", "device_name": "Synergy Marble (Model: Opasm)", "applicant": "Yrs Group, Inc.", "decision_date": "2022-07-22", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Las Vegas", "country_code": "US" }, { "k_number": "K221151", "device_name": "Beauty LED Mask, Model: KFB265", "applicant": "Hunan Guangye Biotechnology Co., Ltd.", "decision_date": "2022-07-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Changsha City", "country_code": "CN" }, { "k_number": "K220168", "device_name": "Skin Care Beauty Mask (Model: MJ-06)", "applicant": "Shenzhen Kaiyan Medical CO , Ltd.", "decision_date": "2022-05-17", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K212947", "device_name": "Trinity Plus Wrinkle Reducer", "applicant": "Carol Cole Company Dba Nuface", "decision_date": "2022-04-02", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Vista", "country_code": "US" }, { "k_number": "K214101", "device_name": "Project E Beauty LED Light Therapy Mask (Model: PE730)", "applicant": "Duplex International Trading Limited", "decision_date": "2022-03-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hong Kong", "country_code": "CN" }, { "k_number": "K210823", "device_name": "LYMA Laser", "applicant": "Lyma Life , Ltd.", "decision_date": "2022-03-18", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "London", "country_code": "GB" }, { "k_number": "K213285", "device_name": "easy Claire", "applicant": "Y & J Bio Co., Ltd.", "decision_date": "2022-03-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hanam-Si", "country_code": "KR" }, { "k_number": "K212771", "device_name": "LightStim Elipsa", "applicant": "Led Intellectual Properties, LLC", "decision_date": "2022-01-26", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K213841", "device_name": "ENEO TOTALE (Model: ENEOT947)", "applicant": "Premier North America, Inc.", "decision_date": "2022-01-06", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Fort Lauderdale", "country_code": "US" }, { "k_number": "K213024", "device_name": "Oren LED Perioral Light Therapy System", "applicant": "Shenzhen Kaiyan Medical CO , Ltd.", "decision_date": "2021-12-22", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K212155", "device_name": "TheraFace LED", "applicant": "Theragun, Inc.", "decision_date": "2021-12-21", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Los Angeles", "country_code": "US" }, { "k_number": "K210965", "device_name": "reVive Light Therapy Essentials", "applicant": "Led Technologies, Inc.", "decision_date": "2021-12-15", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Largo", "country_code": "US" }, { "k_number": "K212275", "device_name": "Dermalux Flex MD", "applicant": "Aesthetic Technology, Ltd.", "decision_date": "2021-11-18", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Warrington", "country_code": "GB" }, { "k_number": "K202390", "device_name": "Aduro Light Beauty Mask", "applicant": "Shenzhen Kaiyan Medical CO , Ltd.", "decision_date": "2021-07-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K200983", "device_name": "Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine", "applicant": "Ningbo Hesi Electric Co., Ltd.", "decision_date": "2021-07-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Ningbo", "country_code": "CN" }, { "k_number": "K210954", "device_name": "Synergy", "applicant": "Yrs Group, Inc.", "decision_date": "2021-06-29", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Las Vegas", "country_code": "US" }, { "k_number": "K202442", "device_name": "Carewear Firefly Wrinkle Reduction", "applicant": "Carewear Corp.", "decision_date": "2020-11-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Statement", "city": "Reno", "country_code": "US" }, { "k_number": "K201107", "device_name": "Opera Lebody (Gold), Opera Lebody (Zafiro)", "applicant": "Gtg Wellness Co., Ltd.", "decision_date": "2020-06-22", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Yongin-Si", "country_code": "KR" }, { "k_number": "K191629", "device_name": "faceLITE", "applicant": "Ismart Marketing Svcs, Ltd.", "decision_date": "2019-09-12", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Birmingham", "country_code": "GB" }, { "k_number": "K190443", "device_name": "MMSphere", "applicant": "Galactic Beauty, LLC", "decision_date": "2019-06-24", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "New York", "country_code": "US" }, { "k_number": "K183247", "device_name": "dpl Faceware", "applicant": "Led Technologies, Inc.", "decision_date": "2019-03-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K183671", "device_name": "LG PRA.L DERMA LED MASK", "applicant": "Lg Electronics.Inc", "decision_date": "2019-01-22", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Pyeongtaek-Si", "country_code": "KR" }, { "k_number": "K180875", "device_name": "POLY REJUV", "applicant": "Medtek Skincare, LLC", "decision_date": "2018-09-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hudson", "country_code": "US" }, { "k_number": "K181659", "device_name": "Avologi ENEO", "applicant": "Premier North America, Inc.", "decision_date": "2018-07-26", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Lauderdale", "country_code": "US" }, { "k_number": "K180856", "device_name": "Neutrogena Light Therapy Aging Mask+", "applicant": "Johnson & Johnson Consumer, Inc.", "decision_date": "2018-06-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Washington", "country_code": "US" }, { "k_number": "K172909", "device_name": "ELEVARE, PERFECTIO 4", "applicant": "Omm Imports D/B/A Zero Gravity", "decision_date": "2018-06-07", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Doral", "country_code": "US" }, { "k_number": "K180445", "device_name": "reVive Light Therapy LED Ultrasonic Wrinkle System", "applicant": "Led Technologies, Inc.", "decision_date": "2018-05-15", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K180320", "device_name": "dpl IIa Panel", "applicant": "Led Technologies, Inc.", "decision_date": "2018-04-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K172662", "device_name": "reVive Perioral", "applicant": "Led Technologies, Inc.", "decision_date": "2018-01-09", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K171323", "device_name": "BIOPHOTAS CELLUMA3", "applicant": "Biophotas, Inc.", "decision_date": "2017-09-01", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Anaheim", "country_code": "US" }, { "k_number": "K170984", "device_name": "LG BEAUTY LED MASK", "applicant": "Lg Electronics", "decision_date": "2017-08-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Pyeongtaek-Si", "country_code": "KR" }, { "k_number": "K171386", "device_name": "dpl SpectraLite", "applicant": "Led Technologies, Inc.", "decision_date": "2017-08-07", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K171390", "device_name": "dpl II Panel", "applicant": "Led Technologies, Inc.", "decision_date": "2017-08-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K163137", "device_name": "NIRA Beauty Skin Laser", "applicant": "Dermal Photonics Corporation", "decision_date": "2017-07-12", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Danvers", "country_code": "US" }, { "k_number": "K163329", "device_name": "Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72", "applicant": "Pulsaderm, LLC", "decision_date": "2017-04-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Myers", "country_code": "US" }, { "k_number": "K162784", "device_name": "Silk'n HST", "applicant": "Home Skinovations , Ltd.", "decision_date": "2017-03-25", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Yokneam", "country_code": "IL" }, { "k_number": "K162489", "device_name": "RED Light Device", "applicant": "Zhongshan Bisen Plastic Electronic Products Co., Ltd.", "decision_date": "2017-01-13", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Zhong Shan", "country_code": "CN" }, { "k_number": "K161849", "device_name": "Bright", "applicant": "Tanda Beauty Canada, Inc.", "decision_date": "2016-07-29", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Cambridge", "country_code": "CA" }, { "k_number": "K152332", "device_name": "Perfectio LED infrared device", "applicant": "Omm Imports Inc Dba Zero Gravity", "decision_date": "2016-02-25", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hallandle", "country_code": "US" }, { "k_number": "K151337", "device_name": "Strialite", "applicant": "Centre Light Solutions, LLC", "decision_date": "2016-02-24", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Mishawaka", "country_code": "US" }, { "k_number": "K151336", "device_name": "LightStim Professional 2-Panel Light", "applicant": "Led Intellectual Properties, LLC", "decision_date": "2015-10-23", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K150098", "device_name": "LightStim Professional 2-Panel Light", "applicant": "Led Intellectual Properties, LLC", "decision_date": "2015-04-09", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K141181", "device_name": "NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES", "applicant": "Led Technologies, LLC", "decision_date": "2015-03-31", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Coralville", "country_code": "US" }, { "k_number": "K140471", "device_name": "PRO X OTC 5", "applicant": "La Lumiere, LLC", "decision_date": "2015-01-15", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Houston", "country_code": "US" }, { "k_number": "K133896", "device_name": "REJUVALITE MD", "applicant": "Trophy Skin, Inc.", "decision_date": "2014-11-13", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Coralville", "country_code": "US" }, { "k_number": "K141308", "device_name": "NUTRA LIGHT RED", "applicant": "Nutra Luxe MD, LLC", "decision_date": "2014-08-20", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Sparks", "country_code": "US" }, { "k_number": "K133546", "device_name": "STARLITE-OM, LIGHT EFFECTS, THIBIANT", "applicant": "Ps Advanced Engineering", "decision_date": "2014-08-06", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Alhambra", "country_code": "US" }, { "k_number": "K132613", "device_name": "SONILASE LIGHT THERAPY DEVICE", "applicant": "Biorenew Labs, LLC", "decision_date": "2014-02-05", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Coralville", "country_code": "US" }, { "k_number": "K133473", "device_name": "ILUMINAGE SKIN SMOOTHING LASER", "applicant": "Cynosure, Inc.", "decision_date": "2014-01-15", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Wesford", "country_code": "US" }, { "k_number": "K124064", "device_name": "YOUNG AGAIN", "applicant": "Espansione Marketing S.P.A", "decision_date": "2013-12-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Imola(Bo)", "country_code": "IT" }, { "k_number": "K130225", "device_name": "QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE", "applicant": "Silverbay, LLC, D/B/A Quasar Bio-Tech", "decision_date": "2013-07-11", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Coralville", "country_code": "US" }, { "k_number": "K120560", "device_name": "TRINITY WRINKLE REMOVER", "applicant": "Carol Cole Company", "decision_date": "2012-11-06", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Poway", "country_code": "US" }, { "k_number": "K112362", "device_name": "C100 WRINKLE REDUCTION DEVICE", "applicant": "Silver Bay, LLC", "decision_date": "2012-08-14", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Knoxville", "country_code": "US" }, { "k_number": "K111454", "device_name": "ILUMINAGE DIODE LASER", "applicant": "Cynosure, Inc.", "decision_date": "2012-07-05", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Wesford", "country_code": "US" }, { "k_number": "K120775", "device_name": "LIGHT FOR WRINKLES", "applicant": "Led Intellectual Properties, LLC", "decision_date": "2012-06-04", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K110301", "device_name": "SILK'N FX", "applicant": "Home Skinovations , Ltd.", "decision_date": "2011-08-19", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Yokneam Illit", "country_code": "IL" }, { "k_number": "K110735", "device_name": "TANDA MAX OTC SYSTEM", "applicant": "Pharos Life Corporation", "decision_date": "2011-08-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Washington", "country_code": "US" }, { "k_number": "K101382", "device_name": "DPL NUVE", "applicant": "Led Technologies, LLC", "decision_date": "2010-11-09", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Boulder", "country_code": "US" }, { "k_number": "K101190", "device_name": "LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC", "applicant": "Led Intellectual Properties, LLC", "decision_date": "2010-07-01", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Santa Ana", "country_code": "US" }, { "k_number": "K092460", "device_name": "STAR-LITE -LM, MODEL SL8809", "applicant": "Ps Advanced Engineering", "decision_date": "2010-03-05", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Alhambra", "country_code": "US" }, { "k_number": "K072459", "device_name": "OMNILUX NEW-U", "applicant": "Photo Therapeutics, Inc.", "decision_date": "2008-03-03", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Carlsbad", "country_code": "US" }, { "k_number": "K062991", "device_name": "GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE", "applicant": "Light Bioscience, LLC", "decision_date": "2008-02-15", "decision_description": "Substantially Equivalent", "product_code": "OHS", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Washington", "country_code": "US" } ] }, "OLP": { "total": 51, "records": [ { "k_number": "K253878", "device_name": "LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)", "applicant": "Shenzhen Kaiyan Medical Equipment Co., Ltd.", "decision_date": "2026-03-04", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K251843", "device_name": "Erchonia EVRL", "applicant": "Erchonia Corporation", "decision_date": "2025-09-12", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fountain Inn", "country_code": "US" }, { "k_number": "K242068", "device_name": "LED Light Therapy Mask (RT01)", "applicant": "Ningbo Dechang Electrical Machinery Made Co.,Ltd", "decision_date": "2025-04-04", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Yuyao", "country_code": "CN" }, { "k_number": "K243555", "device_name": "LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)", "applicant": "Shenzhen Eyco Technology Co., Ltd.", "decision_date": "2025-02-05", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangdong", "country_code": "CN" }, { "k_number": "K232656", "device_name": "BLU TOTALE (Model: ENEOB852)", "applicant": "Premier North America, Inc.", "decision_date": "2023-11-14", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Lauderdale", "country_code": "US" }, { "k_number": "K230490", "device_name": "PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT", "applicant": "Dongguan Hunter Electronic Technology Co., Ltd.", "decision_date": "2023-10-27", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Guangdong", "country_code": "CN" }, { "k_number": "K230720", "device_name": "LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001", "applicant": "Light Tree Ventures Europe B.V.", "decision_date": "2023-07-03", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hague", "country_code": "NL" }, { "k_number": "K213056", "device_name": "LED Facial Mask", "applicant": "Shenzhen Osto Technology Company Limited", "decision_date": "2022-07-07", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Statement", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K220729", "device_name": "The Luminance RED Acne Device", "applicant": "Luminance Medical Ventures, Inc.", "decision_date": "2022-06-09", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dallas", "country_code": "US" }, { "k_number": "K213039", "device_name": "Micro-current facial cold and hot service (model: TPML-100)", "applicant": "Li-Tek Electronics Technology C0., Ltd.", "decision_date": "2022-05-25", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan", "country_code": "CN" }, { "k_number": "K210545", "device_name": "Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine", "applicant": "Marci Beauty, Inc.", "decision_date": "2022-05-20", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Las Vegas", "country_code": "US" }, { "k_number": "K214103", "device_name": "Shani Darden LED light therapy mask", "applicant": "Harpar Grace International", "decision_date": "2022-03-22", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Andover", "country_code": "GB" }, { "k_number": "K210968", "device_name": "reVive Light Therapy Essentials", "applicant": "Led Technologies, Inc.", "decision_date": "2021-12-21", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Largo", "country_code": "US" }, { "k_number": "K213184", "device_name": "MZ Skin LightMAX Supercharged LED Mask 2.0", "applicant": "Mz Skin", "decision_date": "2021-11-23", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "London", "country_code": "GB" }, { "k_number": "K203214", "device_name": "DemarkQ WOW, DemarkQ POP", "applicant": "Shenzhen Kaiyan Medical CO , Ltd.", "decision_date": "2021-07-22", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K203271", "device_name": "Aduro light therapy Handheld", "applicant": "Shenzhen Kaiyan Medical CO , Ltd.", "decision_date": "2021-07-21", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Statement", "city": "Shenzhen", "country_code": "CN" }, { "k_number": "K210948", "device_name": "Omnilux CLEAR", "applicant": "Globalmed Technologies", "decision_date": "2021-06-24", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Napa", "country_code": "US" }, { "k_number": "K202055", "device_name": "Looper (Model: ZX-579S)", "applicant": "Heat IN A Click, LLC", "decision_date": "2021-04-16", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Homestead", "country_code": "US" }, { "k_number": "K192295", "device_name": "PDT-FACE", "applicant": "Beijing Adss Development Co., Ltd.", "decision_date": "2020-05-01", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Beijing", "country_code": "CN" }, { "k_number": "K183708", "device_name": "Poly Clear", "applicant": "Medtek Skincare, LLC", "decision_date": "2019-09-17", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hudson", "country_code": "US" }, { "k_number": "K183118", "device_name": "dpl SpotLite", "applicant": "Led Technologies, Inc.", "decision_date": "2019-02-07", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K180888", "device_name": "LYFT", "applicant": "Uplevity, Inc.", "decision_date": "2018-08-30", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Niantic", "country_code": "US" }, { "k_number": "K180900", "device_name": "LED Light Therapy Device", "applicant": "Uvbiotek, LLC", "decision_date": "2018-07-10", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "New York", "country_code": "US" }, { "k_number": "K180847", "device_name": "Neutrogena Light Therapy Acne Mask+", "applicant": "Johnson & Johnson Consumer, Inc.", "decision_date": "2018-06-19", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Washington", "country_code": "US" }, { "k_number": "K180447", "device_name": "reVive Light Therapy LED Cleansing System", "applicant": "Led Technologies, Inc.", "decision_date": "2018-06-04", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Greenwood Village", "country_code": "US" }, { "k_number": "K172555", "device_name": "SAPPHIRE, ELEVARE SAPPHIRE", "applicant": "Omm Imports, Inc. D/B/A Zero Gravity", "decision_date": "2018-05-01", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Doral", "country_code": "US" }, { "k_number": "K161434", "device_name": "Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)", "applicant": "Li-Tek Electronics Technologies", "decision_date": "2017-09-28", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan City", "country_code": "CN" }, { "k_number": "K170111", "device_name": "Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37", "applicant": "Pulsaderm, LLC", "decision_date": "2017-05-08", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Myers", "country_code": "US" }, { "k_number": "K170260", "device_name": "BC-001+ Acne Purifier", "applicant": "Oriental Inspiration Limited", "decision_date": "2017-04-25", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hong Kong", "country_code": "CN" }, { "k_number": "K162098", "device_name": "LED Phototherapy Device", "applicant": "Li-Tek Electronic Technology Corporation", "decision_date": "2017-01-30", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dongguan", "country_code": "CN" }, { "k_number": "K162371", "device_name": "Pulsaderm ACE-All Blue", "applicant": "Nutra Luxe MD, LLC", "decision_date": "2016-12-15", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Meyers", "country_code": "US" }, { "k_number": "K162450", "device_name": "ESPADA Acne-Clearing Blue Light Pen", "applicant": "Foreo, Inc.", "decision_date": "2016-11-30", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Statement", "city": "Las Vegas", "country_code": "US" }, { "k_number": "K161941", "device_name": "Pulsaderm Acne Device", "applicant": "Nutra Luxe MD, LLC", "decision_date": "2016-10-19", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Myers", "country_code": "US" }, { "k_number": "K160691", "device_name": "Acne Light Therapy Wand", "applicant": "Zuko, Inc.", "decision_date": "2016-06-21", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Wayne", "country_code": "US" }, { "k_number": "K160821", "device_name": "Tria Sapphire", "applicant": "Tria Beauty, Inc.", "decision_date": "2016-06-15", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Dublin", "country_code": "US" }, { "k_number": "K153081", "device_name": "Clear Bi-Light", "applicant": "Michael Todd, LP", "decision_date": "2016-02-15", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Port St Lucie", "country_code": "US" }, { "k_number": "K152889", "device_name": "SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS", "applicant": "Biorenew Labs, LLC", "decision_date": "2015-12-30", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hermosa Beach", "country_code": "US" }, { "k_number": "K150370", "device_name": "Nutra Light Advanced", "applicant": "Nutra Luxe MD, LLC", "decision_date": "2015-07-22", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Fort Myers", "country_code": "US" }, { "k_number": "K142246", "device_name": "LightStim for Acne/ LightStim for Acne Mini", "applicant": "Led Intellectual Properties, LLC", "decision_date": "2015-01-29", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K132833", "device_name": "ULTRA RENEW PLUS", "applicant": "Accord Media", "decision_date": "2014-06-17", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Los Gatos", "country_code": "US" }, { "k_number": "K132838", "device_name": "NUTRA LIGHT BLUE", "applicant": "Nutra Luxe MD, LLC", "decision_date": "2014-05-23", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Sparks", "country_code": "US" }, { "k_number": "K131461", "device_name": "LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI", "applicant": "Led Intellectual Properties, LLC", "decision_date": "2014-01-06", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Irvine", "country_code": "US" }, { "k_number": "K123999", "device_name": "ILLUMASK ACNE LIGHT THERAPY MASK", "applicant": "La Lumiere, LLC", "decision_date": "2013-08-28", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Austin", "country_code": "US" }, { "k_number": "K124042", "device_name": "TANDA MINI SKINCARE SYSTEM", "applicant": "Syneron Beauty", "decision_date": "2013-04-02", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Special", "statement_or_summary": "Summary", "city": "Philedelphia", "country_code": "US" }, { "k_number": "K121435", "device_name": "SILKN BLUE", "applicant": "Home Skinovations , Ltd.", "decision_date": "2013-02-22", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Yokneam Illit", "country_code": "IL" }, { "k_number": "K111937", "device_name": "CLEARFLASH AC2100 COSMETIC SYSTEM", "applicant": "Clearflash Technologies, Inc.", "decision_date": "2012-02-08", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Aliso Viejo", "country_code": "US" }, { "k_number": "K111286", "device_name": "QUASAR CALYPSO", "applicant": "Silver Bay, LLC", "decision_date": "2012-01-18", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Knoxville", "country_code": "US" }, { "k_number": "K102477", "device_name": "NO!NO! SKIN", "applicant": "Radiancy (Israel) , Ltd.", "decision_date": "2010-10-04", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Hod Hasharon", "country_code": "IL" }, { "k_number": "K093963", "device_name": "QUASAR BLUE LIGHT THERAPY SYSTEM", "applicant": "Silver Bay, LLC", "decision_date": "2010-08-27", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Sarasota", "country_code": "US" }, { "k_number": "K090744", "device_name": "CLARO", "applicant": "Clrs Technology Corporation", "decision_date": "2010-04-15", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "North Reading", "country_code": "US" }, { "k_number": "K081307", "device_name": "OMNILUX CLEAR-U", "applicant": "Photo Therapeutics, Inc.", "decision_date": "2009-01-16", "decision_description": "Substantially Equivalent", "product_code": "OLP", "clearance_type": "Traditional", "statement_or_summary": "Summary", "city": "Carlsbad", "country_code": "US" } ] } } }