Omnilux states on omniluxled.com that the Contour Face is "FDA Cleared for the treatment of full face wrinkles." However, a search of the FDA 510(k) database on October 7, 2026 did not surface a 510(k) entry that names the Contour Face specifically. That doesn't prove anything either way — FDA records list manufacturers and device names rather than consumer brand names — but it does mean you should verify before you buy, using the method below.
What the FDA database does show for Omnilux
A 510(k) database search for "Omnilux" on October 7, 2026 returned these listings:
- K210948 — applicant: Globalmed Technologies; device: "Omnilux CLEAR"; decided June 24, 2021 (an acne device)
- Legacy Photo Therapeutics listings: K081307 (OMNILUX CLEAR-U), K030426 (OMNILUX RED), K043329 (OMNILUX REVIVE AND BLUE), K030883 (OMNILUX BLUE), K072459 (OMNILUX NEW-U), K050216 (OMNILUX REVIVE and OMNILUX PLUS), K043317 (OMNILUX PLUS)
None of these entries names the current consumer "Contour Face." The Contour Face may be cleared under a device name or applicant name that doesn't contain "Omnilux" — this happens often, since FDA records use the legal manufacturer and model designation.
How to verify it yourself
- Ask Omnilux for the specific 510(k) (K) number covering the Contour Face — legitimate clearances are public records, and the brand should be able to provide it.
- Search that K number at accessdata.fda.gov (510(k) database) and confirm the applicant, device name, and decision date.
- Compare against a known-good example: Photira's K254007 is listed under applicant "SZ KKS Silicone&Electronic Co., Ltd." with models KKS-225, KKS-280, and KKS-281 — searchable today, which is the standard you should hold every brand to.
Price and spec context (as of October 7, 2026)
The Omnilux Contour Face is listed at $395.00 on omniluxled.com with a 2-year warranty (device and controller, per the brand's spec sheet). The brand's published specs list 633 nm red and 830 nm near-infrared wavelengths with 132 LEDs. For comparison, Photira's $199 everyday price covers red 630 nm, near-infrared 850 nm, and blue 465 nm modes, cleared for wrinkles and mild-to-moderate acne under K254007.
Frequently asked questions
Is the Omnilux Contour Face FDA-cleared?
Omnilux says yes — its site states the Contour Face is "FDA Cleared for the treatment of full face wrinkles." Independently, an FDA 510(k) database search on October 7, 2026 did not return an entry naming the Contour Face specifically; the Omnilux entries found were K210948 (Omnilux CLEAR, acne) and older Photo Therapeutics listings. Ask the brand for the exact K number and verify it yourself.
What 510(k) numbers are associated with Omnilux?
K210948 (Globalmed Technologies, "Omnilux CLEAR," decided June 24, 2021) is the most recent consumer-relevant listing found. Older professional-device listings under Photo Therapeutics include K081307, K030426, K043329, K030883, K072459, K050216, and K043317.
Why can't I find the Contour Face in the FDA database by name?
FDA 510(k) records are filed under the legal manufacturer/applicant and the device/model name — not necessarily the consumer brand name. Searching "Omnilux" or "Contour" may miss a clearance filed under a different applicant or model designation. The K number is the reliable search key.
How much does the Omnilux Contour Face cost?
$395.00 on omniluxled.com as of October 7, 2026, with a 2-year warranty per the brand's spec sheet.
How do I verify any LED mask's FDA clearance?
Get the K number from the brand, search it at accessdata.fda.gov, and match applicant, device/model name, and decision date. A verifiable example: Photira K254007 (applicant "SZ KKS Silicone&Electronic Co., Ltd.," models KKS-225, KKS-280, KKS-281).