Is the Qure Q-Rejuvalight Pro FDA cleared?

Last reviewed August 2026.

Yes — the clearance is real. It just isn't held by the name on the box. K230042 (April 2023) names the exact product — “Q-Rejuvalight Pro Facewear (Model: P19-0023)” — so the claim maps cleanly to a real clearance. The holder is Light Tree Ventures Europe B.V., the OEM whose paper also sits behind Solawave's Wrinkle Retreat and the LUSTRE and myLEDmask lines; Qure itself appears nowhere in the 510(k) index. The listing carries both wrinkle and acne product codes, matching the two-part marketing claim. The “world's first customizable” half of the sentence is a marketing superlative outside any FDA record — the record neither supports nor contradicts it, and we don't rank superlatives.

The record on file

Sources — read the record yourself

• FDA 510(k) K230042 — Q-Rejuvalight Pro Facewear, Light Tree Ventures (2023)
• Qure — Q-Rejuvalight Pro product page (claim, 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.

Some product links on this page are affiliate links: as an Amazon Associate we earn from qualifying purchases, at no extra cost to you. Affiliate status never changes a ranking or a verdict — full affiliate disclosure.