What each FDA record says
| From the record | Solawave Wrinkle Retreat Pro | Omnilux Contour Face |
|---|---|---|
| 510(k) number | K252983 (Dec 17, 2025) | K191629 (Sep 12, 2019) |
| Device name on the 510(k) | Wrinkle Retreat Pro Light Therapy Face Mask (PH-m03) | faceLITE |
| Indications for use | Full-face wrinkles | Full-face wrinkles |
| Wavelengths in the filing | Amber 605, red 630, deep red 660, near-infrared 830 nm (±5) | Red 630, near-infrared 830 nm (±10) |
| Treatment time in the filing | 3 minutes | 10 minutes, 5 times a week for 6 weeks |
| Battery in the filing | Rechargeable lithium, in the controller | Rechargeable lithium-ion polymer, in the controller |
| LED count | 320, per solawave.co | Not in the filing text we read |
Read in the 510(k) filing PDFs at accessdata.fda.gov on 5 October 2026. Search the same numbers in the 510(k) database.
What the records show
Same indication, different light. Both are cleared for full-face wrinkles and neither for acne. The Solawave filing lists four wavelengths, adding amber at 605 nm and deep red at 660 nm to the red and near-infrared pair that the Omnilux filing lists.
Session length is the biggest practical difference on paper. The Solawave filing gives a 3-minute treatment; the Omnilux filing gives 10 minutes, five times a week for six weeks. Solawave's site recommends its 3 minutes 3 to 5 times a week.
How each record matches the mask on sale. Solawave's mask is on record under its own name: the 510(k) device name matches, and GUDID lists a Solawave Wrinkle Retreat Pro with the same model number, PH-m03, made by Shenzhen Goodwind Technology Development. Solawave's retail item number, 61137-T, does not appear in GUDID, so the match rests on the name, the four wavelengths and the 3-minute treatment, which agree between the filing and solawave.co. The Omnilux record is under a different name: the GUDID entry for the Contour Face cites K191629, issued in 2019 for a device named faceLITE.
Which one fits
If a short session is what decides whether you keep using a mask, the Solawave filing's 3 minutes against 10 is the clearest difference between the two. If you are fine with a 10-minute session and want the flexible silicone mask its filing describes, the Omnilux is that option; our Omnilux review has its full record. Neither record covers acne; for that, see Shark CryoGlow vs Omnilux vs CurrentBody.
We compare published specifications and public FDA records; no hands-on testing of these devices took place.