Is the LightStim for Wrinkles FDA cleared?

Last reviewed July 2026.

Yes — and the paper has the brand's own name on it. The oldest paper in the ranking, and it belongs to the brand: LED Intellectual Properties, LLC — LightStim's IP arm — has held OHS clearances since 2010 (K101190) with K120775 covering the wrinkle device in 2012, and later filings for the professional panels and the acne device. It is a handheld wand-style panel rather than a wearable mask, which is also why it is the cheapest verified row in the table. One honest gap: the product page names its four light colors but publishes no nanometer values — the only ranked row without printed wavelengths.

The record on file

Sources — read the record yourself

• FDA 510(k) K120775 — Light for Wrinkles, LED Intellectual Properties (2012)
• LightStim — for Wrinkles product page (claim, price)

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.