What each FDA record says
| From the record | Shark CryoGlow | Omnilux Contour Face | CurrentBody Series 2 |
|---|---|---|---|
| 510(k) number | K242796 (Nov 27, 2024) | K191629 (Sep 12, 2019) | K250966 (Jun 25, 2025) |
| Device name on the 510(k) | CryoGlow (FW3XXXX) | faceLITE | CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) |
| Indications for use | Fine lines and wrinkles; mild-to-moderate inflammatory acne | Full-face wrinkles | Full-face wrinkles |
| Wavelengths in the filing | Red 630, blue 415, infrared 830 nm (±10) | Red 630, near-infrared 830 nm (±10) | Red 633, near-infrared 830 nm |
| LEDs in the filing | 480 (160 tri-wick packages) | Not in the filing text we read | 220 (110 at 633 nm, 110 at 830 nm) |
| Mask body in the filing | Molded plastic | Flexible silicone | Flexible silicone |
| Treatment in the filing | Varies by mode | 10 minutes, 5 times a week for 6 weeks | 10 minutes, 5 times a week for 6 weeks |
Read in the 510(k) filing PDFs at accessdata.fda.gov on 5 October 2026. Search the same numbers yourself in the 510(k) database; how we match records to the masks sold today is on our clearance check page.
Three things the records show
Only the CryoGlow is cleared for acne. Its indication covers fine lines and wrinkles with red and infrared light, and mild-to-moderate inflammatory acne with red, blue and infrared. The filing puts the blue LED at 415 nm. The Omnilux and CurrentBody filings are for full-face wrinkles only, and neither lists a blue wavelength.
The Omnilux record carries a different name. The GUDID entry for the Contour Face cites K191629, a clearance issued in 2019 for a device named faceLITE, applicant Ismart Marketing Svcs, Ltd. The other two masks are on record under their own names (Shark's with a model pattern, FW3XXXX, that covers the FW312PL sold on Amazon).
CurrentBody's own spec goes beyond its filing. CurrentBody lists 236 LEDs, including 16 at 1072 nm. The 510(k) filing for model MK-90H lists 220 LEDs at 633 and 830 nm and no 1072 nm wavelength. Both statements are in our catalog with their sources; we have not found a record that covers the 1072 nm LEDs.
Which one fits
If breakouts are part of why you want a mask, the CryoGlow is the one of the three whose clearance covers acne. It also adds under-eye cooling, which its filing describes as refreshing the skin rather than as a treatment. If wrinkles are the only goal and you want a flexible silicone mask, the Omnilux and CurrentBody filings describe that design and the same 10-minute, five-times-a-week protocol. Our Omnilux and CurrentBody reviews and the CurrentBody vs Omnilux comparison go into those two in more detail.
We compare published specifications and public FDA records; no hands-on testing of these devices took place.