Is the CurrentBody Skin LED Mask Series 2 FDA cleared?

Last reviewed July 2026.

Yes — the clearance is real. It just isn't held by the name on the box. The cleanest OEM row in the table: K250966 (June 2025) names the exact product — “CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)” — so there is no name gap, but the applicant and holder is Shenzhen Kaiyan Medical Equipment Co., the contract manufacturer, not CurrentBody. One detail worth reading twice on the product page: the specification block's certification field says “UKCA registered” while the heading says “FDA cleared” — both can be true; they are different registers in different countries. CurrentBody's own earlier masks rode Light Tree Ventures' K221775, and its parent company also lists Omnilux Contour — see the OEM guide for the family tree.

The record on file

Sources — read the record yourself

• FDA 510(k) K250966 — CurrentBody Skin LED Series 2, Shenzhen Kaiyan (2025)
• CurrentBody US — Series 2 product page (claim, price, wavelengths, “UKCA registered” field)

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.