Is the Omnilux Contour Face FDA cleared?

Last reviewed July 2026.

Yes — the clearance is real. It just isn't held by the name on the box. The clearance is real — and it is not Omnilux's. FDA's registration & listing database shows “Omnilux Contour” listed under K191629, a 510(k) granted in September 2019 to Ismart Marketing Svcs, Ltd. of Birmingham, UK, for a device named faceLITE. The same I-SMART listing carries eighteen other brand names — PRIORI, faceLITE, Smoothskin DuoLux, Glo mask, Deesse Pro Express, City Beauty's mask and more — and CurrentBody's parent, The Beauty Tech Group, lists “Omnilux contour” under the same K-number. Riding a licensor's clearance is legal and common; the record simply says the paper behind the best-known mask in the category names a different device and a different company.

The record on file

Sources — read the record yourself

• FDA 510(k) K191629 — faceLITE, Ismart Marketing Svcs (2019)
• FDA registration & listing — “Omnilux Contour” under K191629 (openFDA index)
• Omnilux — Contour Face product page (price, wavelengths)
• Omnilux — help center (“All Omnilux devices have been FDA cleared”)

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.

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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.