FTC · Light, Ultraviolet, Dermatological
General, Plastic Surgery · 21 CFR 878.4630 · Class 2
Overview
| Product Code | FTC |
|---|---|
| Device Name | Light, Ultraviolet, Dermatological |
| Regulation | 21 CFR 878.4630 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 271)
Showing 20 most recent of 271 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253871 | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | Mar 4, 2026 | SESE |
| K250425 | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | Apr 7, 2025 | SESE |
| K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | Boston Aesthetics, Inc. | Mar 13, 2025 | SESE |
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) | Xuzhou Kernel Medical Equipment Co., Ltd. | Feb 6, 2025 | SESE |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. | Dec 19, 2024 | SESE |
| K233811 | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | Dec 13, 2023 | SESE |
| K223882 | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | Mar 27, 2023 | SESE |
| K230382 | 3 Series NeoLux | Daavlin Distributing Co. | Mar 24, 2023 | SESE |
| K230076 | Enhanced AURORA Medical Diode System, and related accessories | Psoria-Shield, Inc. | Mar 8, 2023 | SESE |
| K220840 | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | Apr 22, 2022 | SESE |
| K210004 | i8 Tanning Booth | Ultrasun International B.V. | Dec 10, 2021 | SESE |
| K212510 | 7 Series Phototherapy Device | Daavlin Distributing Co. | Nov 4, 2021 | SESE |
| K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | Jun 22, 2021 | SESE |
| K202827 | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | Dec 15, 2020 | SESE |
| K200971 | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | Dec 15, 2020 | SESE |
| K192411 | Psoria-Shield AURORA | Psoria-Shield | Jul 2, 2020 | SESE |
| K192642 | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | May 13, 2020 | SESE |
| K191571 | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Feb 6, 2020 | SESE |
| K191086 | Exciplex | Clarteis | Dec 11, 2019 | SESE |
| K181805 | UV Phototherapy | Xuzhou Kernel Medical Equipment Co., Ltd. | Jan 11, 2019 | SESE |
Top Applicants
- National Biological Corp. — 26 clearances
- Daavlin Distributing Co. — 14 clearances
- Philips Int'L B.V. — 9 clearances
- Light Sources, Inc. — 8 clearances
- Mottek Intl. Corp. — 8 clearances
