FDA 510(k) records
Each device here has an FDA 510(k) record we could link. Three records name the device directly, two match by model or device name, and five are possible matches we could not confirm. Clearance means substantial equivalence, not proof of effect.
LED face masks
| Device | 510(k) | Device on record | Applicant | Decision | Code | Match |
|---|---|---|---|---|---|---|
| CurrentBody Series 3 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026-06-03 | OHS | Possible match, unconfirmed |
| Dr. Dennis Gross FaceWare Pro | K183247 | dpl Faceware | Led Technologies, Inc. | 2019-03-14 | OHS | Possible match, unconfirmed |
| Dr. Renú SpectraLift | K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071 and related models) | Shenzhen Rainbow Technology Co., Ltd. | 2026-01-23 | OHS | Matched by model or device name |
| Omnilux Contour | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019-09-12 | OHS | Possible match, unconfirmed |
| Shark CryoGlow | K242796 | CryoGlow (FW3XXXX) | SharkNinja Operating, LLC | 2024-11-27 | OHS | Record names this device |
At-home lasers
| Device | 510(k) | Device on record | Applicant | Decision | Code | Match |
|---|---|---|---|---|---|---|
| LYMA Laser | K210823 | LYMA Laser | Lyma Life, Ltd. | 2022-03-18 | OHS | Record names this device |
| LYMA Laser PRO | K243330 | LYMA Laser PRO | Lyma Life, Ltd. | 2025-02-21 | OHS | Record names this device |
| MimiSilk Iris | K182498 | Advanced Skin Renewing Device | Jiangsu Unimed Laser Technology Co., Ltd. | 2018-11-30 | ONG | Matched by model or device name |
| NIRA Pro 3 | K222685 | NIRA Model 2 | Dermal Photonics Corp | 2023-02-08 | OHS | Possible match, unconfirmed |
| Tria FRX | K141868 | TRIA FANP | Tria Beauty, Inc. | 2014-12-30 | ONG | Possible match, unconfirmed |
Product codes
- OHS: light-based over-the-counter wrinkle reduction
- ONG: powered laser surgical instrument with microbeam/fractional output
What 510(k) clearance means
A 510(k) clearance means the FDA found a device substantially equivalent to a device already legally marketed in the US. It does not mean the FDA has judged that it works better than other devices, and it does not cover models released after the record unless the manufacturer files again or the change is minor. Records often name the contract manufacturer rather than the brand.
Records searched in the FDA 510(k) database and openFDA on 3 November 2026.