Is the Therabody TheraFace Mask FDA cleared?

Last reviewed July 2026.

Yes — and the paper has the brand's own name on it. Therabody filed K230293 in its own name in June 2023, naming the TheraFace Mask exactly; the listing carries both wrinkle and acne codes, and earlier TheraFace attachments (K212155, K212238) show the company has been filing its own paper since 2021. Nothing in the record distinguishes its clearance from a $349 competitor's — a 510(k) is a safety-and-equivalence review, not a performance ranking, which is worth remembering at $649.99. The vibration/massage features sit outside the light-therapy record entirely.

The record on file

Sources — read the record yourself

• FDA 510(k) K230293 — TheraFace Mask, Therabody (2023)
• Therabody — TheraFace Mask product page (claim, price, wavelengths)

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.