Is the MZ Skin LightMAX 2.0 FDA cleared?

Last reviewed July 2026.

Yes — the clearance is real. It just isn't held by the name on the box. K213184 (November 2021) names the LightMAX 2.0 exactly, with MZ Skin as applicant — but the clearance correspondence is signed by the owner of iSMART, and FDA's listing index files the mask under I-SMART Development Ltd., the same Birmingham constellation whose faceLITE clearance (K191629) sits behind Omnilux Contour, PRIORI, Deesse and a dozen other names. “Medical grade” is a marketing phrase with no FDA definition — the record says Class II, 510(k)-cleared, like every other mask in this table. Unranked only because mzskin.com publishes GBP pricing (£750) and no first-party USD price: no verified price, no rank.

The record on file

Sources — read the record yourself

• FDA 510(k) K213184 — MZ Skin LightMAX 2.0 (2021; correspondent: iSMART)
• FDA 510(k) K213184 decision PDF (iSMART correspondence on page 1)
• MZ Skin — LightMAX 2.0 product page (claim, GBP 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.