The OEM behind your mask: whose K-number the category actually rides

Last reviewed July 2026.

Count the clearances and the category inverts. In the FDA's 510(k) database, the biggest holders of LED-mask clearances are not the brands you've heard of — they are manufacturers and licensing constellations most buyers have never seen named. Riding someone else's clearance is legal and routine: a brand licenses or white-labels a cleared device, lists its product under the OEM's K-number, and prints "FDA cleared" on the box — truthfully. The record simply knows things the box doesn't say. Here are the four constellations behind much of what's on the shelf, from the FDA's own database.

Shenzhen Kaiyan Medical — the biggest filer in the category

Kaiyan holds more OTC light-therapy skin-device clearances than anyone else in the record — 18 under the wrinkle and acne codes at our last pull. Its paper sits behind CurrentBody's Series 2 mask (K250966 — which names the CurrentBody product exactly, with Kaiyan as holder), HigherDOSE's mask (K241933), Solawave's wand and Mini (K232863, K250532), and a roll-call of other brand names in the listing index: KALA, ORA Method, TRUDERMAL, Aduro. When a mask's model number starts with "MK," you are often looking at the same family of molds sold under different logos — HigherDOSE's mask is the MK66-L; masks cleared under Light Tree's K221775 include the MK66-H and MK66R-B.

Light Tree Ventures — one generic clearance, many boxes

Light Tree Ventures Europe B.V. holds 7 clearances, including K221775 (December 2022) for a device named, in full, "LED Light Therapy Mask" across five model numbers — the paper FDA's index shows behind Solawave's Wrinkle Retreat mask — and K230042, which names Qure's Q-Rejuvalight Pro exactly. The LUSTRE and myLEDmask lines ride Light Tree paper too. Qure's marketing says "FDA-cleared"; the FDA record agrees, and adds the part the marketing omits: the holder is Light Tree, and Qure appears nowhere in the 510(k) index.

The iSMART constellation — nineteen brands, one listing

The most striking record in the index: I-SMART Development Ltd. of Birmingham, UK — an establishment whose FDA type is literally "develop specifications but do not manufacture" — lists a single device entry that carries nineteen proprietary names, including "Omnilux Contour," "Omnilux Mens," PRIORI, faceLITE, Smoothskin DuoLux, Glo mask, Deesse Pro Express, Kandyway, and City Beauty's mask. The K-number behind the $395 Omnilux Contour Face is K191629 — a 2019 clearance for a device named faceLITE, held by Ismart Marketing Svcs, Ltd. MZ Skin's £750 LightMAX 2.0 has its own K-number (K213184) — with iSMART's owner signing the clearance correspondence. Even CurrentBody's parent, The Beauty Tech Group, lists "Omnilux contour" under K191629: the premium tier of this category is more intertwined than any of its brand stories suggest. And one brand bridges the constellations outright: The Light Salon's Boost is listed under K191629 (the faceLITE paper, beside Omnilux) while its newer Boost Advanced rides Light Tree's K221775 (Solawave's paper) — the same £395 mask family, two different OEMs' K-numbers across generations, with an ILY no-K infrared-lamp listing for the neck "Bib" on the side.

LED Technologies — the American original

LED Technologies, Inc. (dpl, reVive) has been filing its own paper since the 2000s — 11 clearances across the wrinkle and acne codes, including K171386 (2017) for a device named "dpl SpectraLite." That name matters because Dr. Dennis Gross's DRx SpectraLite FaceWare Pro — marketed "This device is FDA Cleared!" — matches no K-number under its own name in the public index; the only SpectraLite in the record is LED Technologies'. A licensing arrangement would be unsurprising and legal — but unlike every ranked row on this site, no public record we searched connects that product to its paper.

What this means when you're buying

An OEM-held clearance is not a defect — Kaiyan's and Light Tree's paper names some of the best-selling masks in the world, and two mass-market brands (SharkNinja, Therabody) plus two specialists (LightStim, FOREO) hold their own. But the holder column explains real things: why a brand-name search of the FDA database comes up empty for a cleared mask, why near-identical masks appear under many logos at very different prices, and why "FDA cleared" on the box is the beginning of the question rather than the end of it. The table names the holder on every row →

Sources — read them yourself

• FDA 510(k) K191629 — faceLITE, Ismart Marketing Svcs (2019)
• FDA 510(k) K250966 — CurrentBody Skin Series 2, Shenzhen Kaiyan (2025)
• FDA 510(k) K221775 — "LED Light Therapy Mask," Light Tree Ventures (2022)
• FDA 510(k) K171386 — dpl SpectraLite, LED Technologies (2017)
• FDA registration & listing index — search any brand yourself

LED Mask Score indexes claims against the FDA's public record, with links — we test nothing and give no medical advice. Holder facts above are from the FDA's 510(k) and registration & listing databases as of July 2026; if a record changes, the page changes.