LED mask FDA-clearance guides

Last reviewed August 2026.

Every mask we track, plus the record guides. Each mask page answers one question — is it FDA cleared? — with the marketing claim quoted, the K-number and its holder named, and the FDA record linked.

Start here: The best LED face mask — ranked by measured irradiance, and why FDA clearance matters as much.

The measurement

• What measured irradiance actually means — and why LED count doesn't

FDA cleared, mask by mask

• Is the Omnilux Contour Face FDA cleared?
• Is the CurrentBody Skin LED Mask Series 2 FDA cleared?
• Is the Shark CryoGlow FDA cleared?
• Is the Solawave Wrinkle Retreat FDA cleared?
• Is the LightStim for Wrinkles FDA cleared?
• Is the Qure Q-Rejuvalight Pro FDA cleared?
• Is the HigherDOSE Red Light Face Mask FDA cleared?
• Is the Therabody TheraFace Mask FDA cleared?
• Is the FOREO FAQ 202 FDA cleared?
• Is the MZ Skin LightMAX 2.0 FDA cleared?
• Is the The Light Salon Boost FDA cleared?
• Is the Dr. Dennis Gross SpectraLite FaceWare Pro FDA cleared?
• Is the VogueNow LED Mask FDA cleared?
• Is the Aphrona MOONLIGHT PRO FDA cleared?

The record

• “FDA cleared,” “FDA registered,” “FDA approved”: three phrases, one that means a device review
• The OEM behind your mask: whose K-number the category's biggest names actually ride
• The Neutrogena recall and the eye-safety record: what MAUDE reports are and aren't
• Why red-light panels aren't FDA cleared — and why that's usually not a red flag

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.

Some product links on this page are affiliate links: as an Amazon Associate we earn from qualifying purchases, at no extra cost to you. Affiliate status never changes a ranking or a verdict — full affiliate disclosure.