Is the VogueNow LED Mask FDA cleared?

Last reviewed July 2026.

Yes — the clearance is real. It just isn't held by the name on the box. The representative Amazon-tier row. FDA's listing index maps “VogueNow LuminX Pro (RB-008G)” to K243423, a January 2025 clearance held by Shenzhen Rainbow Technology for its RB-series masks — so the brand's FDA language is not invented. What the Amazon listing never states is which model you receive and whether it is one of the cleared RB numbers; the title says “Wrinkles & Acne” while the matched K covers the wrinkle code. No first-party site, no first-party price, model-scope unstated: everything about the row is checkable except the thing you'd actually buy. That is the Amazon tier in one sentence, and why it sits below the line without a purchase link.

The record on file

Sources — read the record yourself

• FDA 510(k) K243423 — LED Light Therapy Mask (RB-series), Shenzhen Rainbow (2025)
• Amazon — VogueNow LED mask listing (claim in title)

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.