Is the The Light Salon Boost FDA cleared?

Last reviewed July 2026.

Yes — the clearance is real. It just isn't held by the name on the box. The clearest single exhibit of how this category's paper actually works. FDA's listing index shows The Light Salon's masks riding both of the record's big constellations: the original “Light Salon Boost” sits under K191629 — the 2019 faceLITE clearance held by Ismart Marketing, the same paper behind Omnilux Contour (The Beauty Tech Group lists both names in one entry) — while the newer “Boost Advanced LED Face Mask” is listed under K221775, Light Tree Ventures' generic-mask clearance, the same paper behind Solawave's Wrinkle Retreat, with Shenzhen Kaiyan appearing as a lister. Both clearances are real; neither is The Light Salon's own. The same brand's “LED Bib” neck piece sits on an ILY infrared-lamp listing with no K-number at all — the exact pattern our panels guide describes. A MAUDE adverse-event report exists for the Boost Advanced, as for other cleared masks in the table. Unranked for one reason: thelight-salon.com publishes GBP pricing and no first-party USD price — no verified price, no rank, the same rule every row gets.

The record on file

Sources — read the record yourself

• FDA 510(k) K191629 — faceLITE, Ismart Marketing Svcs (2019): the original Boost's listed paper
• FDA 510(k) K221775 — LED Light Therapy Mask, Light Tree Ventures (2022): the Boost Advanced's listed paper
• openFDA registration & listing — “Light Salon Boost” under K191629; “Boost The Light Salon Advanced LED Face Mask” under K221775 (checked 2026-07-16)
• The Light Salon — Boost LED Face Mask product page (claim, £395, wavelengths, LED counts)
• FDA MAUDE — adverse-event report, Boost Advanced LED Light Therapy Face Mask
• The Light Salon — Boost FAQs (cites 510(K) No. K191629)

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.