Is the Solawave Wrinkle Retreat FDA cleared?

Last reviewed July 2026.

Yes — the clearance is real. It just isn't held by the name on the box. FDA's listing index maps “Solawave Wrinkle Retreat Light Therapy Face Mask” to K221775 — a December 2022 clearance held by Light Tree Ventures Europe B.V. for a device named, in full, “LED Light Therapy Mask” across five model numbers. Two things are worth knowing. First, the paper is an OEM's, filed years before Solawave's mask launched under it — legal, common, and invisible from the box. Second, the page we checked now sells a “Wrinkle Retreat Pro” (320 LEDs, 4 wavelengths); the name in the FDA listing is the non-Pro mask, and no listing under the Pro name surfaced in the public index when we checked. If Solawave publishes the Pro's own listing or K-number, this row changes — the record wins. Solawave's other devices sit on different paper: the 4-in-1 wand on K232863, the 2-in-1 Mini on K250532, both filed by Shenzhen Kaiyan.

The record on file

Sources — read the record yourself

• FDA 510(k) K221775 — LED Light Therapy Mask, Light Tree Ventures (2022)
• Solawave — Wrinkle Retreat product page (claim, price, wavelengths)
• FDA 510(k) K250532 — Solawave 2-in-1 Skincare Mini, filed by Shenzhen Kaiyan (2025)

How to read this

“FDA cleared” means a 510(k): the FDA reviewed the device as substantially equivalent to one already on the market and assigned a K-number you can look up. It is not “FDA approved” (a drug/high-risk standard no LED mask meets), and it is nothing like “FDA registered,” which only means a factory is on a list — the three phrases, decoded. Many real clearances are held by OEMs and licensors rather than the brand on the box — who actually holds the category's paper. A clearance is a safety review, not a results guarantee, and adverse-event reports exist for cleared masks — the eye-safety record.

See every mask we track, claim by claim → · the claims we couldn't match →

LED Mask Score indexes manufacturers' FDA marketing claims against the FDA's own public record — the 510(k) database and the registration & listing index — with links, so you can read the paper yourself. We test nothing and give no medical or skincare advice. A 510(k) clearance is a safety-and-equivalence review, not a performance ranking, an endorsement, or an "FDA approval." If a brand publishes a K-number or listing that changes a row, the page changes — the record wins.