Is the Shark CryoGlow FDA cleared?

Last reviewed July 2026.

Yes — and the paper has the brand's own name on it. SharkNinja filed K242796 in its own name in November 2024, covering the CryoGlow family (FW3XXXX), and its FDA listing carries both the wrinkle (OHS) and acne (OLP) product codes — the claim on the box and the paper behind it have the same name on them. Contract manufacturers in Vietnam and China appear in the listing index without their own K-numbers, which is the normal shape of a brand-held clearance. MAUDE adverse-event reports exist for this device, as they do for other masks in the table — reports are indexed, not judged, in our eye-safety guide.

The record on file

Sources — read the record yourself

• FDA 510(k) K242796 — CryoGlow, SharkNinja Operating (2024)
• Shark — CryoGlow FW312 product page (claim, price)
• FDA MAUDE — example adverse-event report, Shark CryoGlow

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.