Is the LightStim for Wrinkles FDA cleared?
Last reviewed October 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. The product page publishes all four nanometer values — amber 605 nm, light red 640 nm, dark red 652 nm and infrared 850 nm — in the How Light Therapy Works panel, read there on 2026-09-22. This row previously recorded them as unpublished, which was wrong: the figures are printed in that panel rather than in the product copy, so a reading that only took in the prose missed them. Checked again on 2026-08-28 against the FDA's own 510(k) record: LED Intellectual Properties cleared K261482 on 2026-07-31, device name “LightStim for Wrinkles (1984); LightStim for Acne (2038)” — the first filing to name the retail product explicitly rather than the generic “LIGHT FOR WRINKLES” of 2012. The old paper is not stale paper; it has been renewed five weeks ago.
The record on file
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| Verdict | Brand-held K — Cleared — the brand holds its own K-number |
| K-number | K120775 · decided 2012-06-04 · device name “LIGHT FOR WRINKLES” |
| Holder | LED Intellectual Properties, LLC |
| Cleared for | Wrinkles (OHS) |
| Wavelengths | Amber 605 nm, light red 640 nm, dark red 652 nm, infrared 850 nm |
| The claim | “LightStim for Wrinkles is FDA Cleared to treat fine lines and wrinkles on the entire face using LED light therapy” (lightstim.com product page) Amazon ↗ |
Sources — read the record yourself
- FDA 510(k) K120775 — Light for Wrinkles, LED Intellectual Properties (2012)
- LightStim — for Wrinkles product page (claim)
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.
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