Checking the FDA claims.
Five of the five compared masks have a 510(k) record we could link to them in the FDA database: 3 confirmed by name or model number, 2 possible. No had no record under their brand or model name. Clearance shows substantial equivalence for a stated use; it is not a measure of how well a mask works.
Records found
- CurrentBody Skin LED Face Mask Series 3K260715 · Possible match, unconfirmed
- Dr. Dennis Gross DRx SpectraLite FaceWare ProK183247 · Possible match, unconfirmed
- Dr. Renú SpectraLift AdvancedK253712 · Matched by model number
- Omnilux Contour FaceK191629 · Matched by model number
- Shark CryoGlow FW312K242796 · FDA record names this model
CurrentBody Series 3. K260715, cleared 3 Jun 2026 (Possible match, unconfirmed). Record: “CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)”, The Beauty Tech Group, Ltd. A recent CurrentBody mask clearance; the record does not say “Series 3”, so the match is unconfirmed.
Dr. Dennis Gross FaceWare Pro. K183247, cleared 14 Mar 2019 (Possible match, unconfirmed). Record: “dpl Faceware”, Led Technologies, Inc. A “Faceware” device cleared for LED Technologies; the record does not name Dr. Dennis Gross or the Pro model.
Dr. Renú SpectraLift. K253712, cleared 23 Jan 2026 (Matched by model number). Record: “LED Light Therapy Mask (RB-051, RB-061, RB-071 and related models)”, Shenzhen Rainbow Technology Co., Ltd. Dr. Renú’s device documentation cites K253712 and model RB-061. The FDA record lists RB-061 among the covered models under the manufacturer’s name, not the brand name.
Omnilux Contour. K191629, cleared 12 Sept 2019 (Matched by model number). Record: “faceLITE”, Ismart Marketing Svcs, Ltd. Official AccessGUDID record 05060534510128 names Omnilux Contour FACE, model TN19G, and lists K191629. The clearance itself is titled faceLITE.
Shark CryoGlow. K242796, cleared 27 Nov 2024 (FDA record names this model). Record: “CryoGlow (FW3XXXX)”, SharkNinja Operating, LLC. The FDA record names the CryoGlow model family.
No record found
No record under the brand name does not prove a mask is not cleared: devices are often cleared under the factory’s name and model numbers. Ask the brand for its K-number and check it yourself.
How we checked
We searched the FDA 510(k) database (openFDA) by brand, model and known K-numbers on 31 October 2026. “Confirmed” means the FDA record names the model; “matched by model number” means the brand cites the K-number and the record lists that model; “possible” means a related record that does not name the exact model.
What clearance does and does not mean
A 510(k) clearance lets a device be sold in the US for its stated use because it is substantially equivalent to a legally marketed predicate. It is not FDA approval, it does not compare devices with each other, and it does not rank results. Most LED face masks are cleared under product code OHS, over-the-counter light-based wrinkle reduction. Check any claim in the FDA 510(k) database.
Questions
Which LED face masks are FDA cleared?
Records linked by name or model number: Dr. Renú SpectraLift (K253712), Omnilux Contour (K191629) and Shark CryoGlow (K242796). Possible matches: CurrentBody Series 3 (K260715) and Dr. Dennis Gross FaceWare Pro (K183247).
Does FDA cleared mean the mask works better?
No. Clearance shows substantial equivalence to an existing device for a stated use. It does not compare results between devices.
Is FDA cleared the same as FDA approved?
No. Approval is a separate, stricter pathway used mainly for higher-risk devices. LED masks are generally cleared, not approved.