FTC
- Product code
- FTC
- Device name
- Light, Ultraviolet, Dermatological
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4630
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 272 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254234 | 2026-05-01 | Choyang Medics Co., Ltd. | Phototherapy System (DUV-COMBO) | |
| K253871 | 2026-03-04 | Radcliffe Watts, LLC | Klär Lite (RCW-KL1000) | FDA |
| K250425 | 2025-04-07 | APK Technology Co., Ltd. | Ultraviolet Phototherapy Device | — |
| K244022 | 2025-03-13 | Boston Aesthetics, Inc. | 308nm UV Phototherapy System (UV-K); 308nm UV Photot… | |
| K242977 | 2025-02-06 | Xuzhou Kernel Medical Equipment Co., L… | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B… | |
| K242908 | 2024-12-19 | Shanghai Sigma High-Tech Co., Ltd. | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PC… | |
| K233811 | 2023-12-13 | Daavlin Distributing Co. | DT Controlled Phototherapy Equipment |
Official FDA classification page: FTC
Classification and pathway per current FDA publications. Data from openFDA (CC0).