FTC — Light, Ultraviolet, Dermatological Class II
FDA product code FTC covers "Light, Ultraviolet, Dermatological", a Class II medical device regulated under 21 CFR 878.4630. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FTC
- Device Class
- Class II
- Regulation Number
- 878.4630
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254234 | choyang medics co | Phototherapy System (DUV-COMBO) | May 1, 2026 |
| K253871 | radcliffe watts | Klär Lite (RCW-KL1000) | March 4, 2026 |
| K250425 | apk technology co | Ultraviolet Phototherapy Device | April 7, 2025 |
| K244022 | boston aesthetics | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm | March 13, 2025 |
| K242977 | xuzhou kernel medical equipment co | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-50 | February 6, 2025 |
| K242908 | shanghai sigma high-tech co | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, | December 19, 2024 |
| K233811 | daavlin distributing | DT Controlled Phototherapy Equipment | December 13, 2023 |
| K223882 | shenzhen honpal optoelectronic technology co | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | March 27, 2023 |
| K230382 | daavlin distributing | 3 Series NeoLux | March 24, 2023 |
| K230076 | psoria-shield | Enhanced AURORA Medical Diode System, and related accessories | March 8, 2023 |
| K220840 | daavlin distributing | 1 Series Phototherapy Equipment | April 22, 2022 |
| K210004 | ultrasun international | i8 Tanning Booth | December 10, 2021 |
| K212510 | daavlin distributing | 7 Series Phototherapy Device | November 4, 2021 |
| K210881 | daavlin distributing | M Series Phototherapy Equipment | June 22, 2021 |
| K200971 | xuzhou kernel medical equipment co | 308nm Excimer System | December 15, 2020 |
| K202827 | shenzhen gsd tech co | 308nm Excimer UV-light Skin Therapy System | December 15, 2020 |
| K192411 | psoria-shield | Psoria-Shield AURORA | July 2, 2020 |
| K192642 | chongqing peninsula medical technology co | 308nm Excimer System | May 13, 2020 |
| K191571 | xuzhou yongkang electronic science technology co | UV Radiation Treatment System | February 6, 2020 |
| K191086 | clarteis | Exciplex | December 11, 2019 |