Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4630](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4630) → FTC — Light, Ultraviolet, Dermatological # FTC · Light, Ultraviolet, Dermatological _General, Plastic Surgery · 21 CFR 878.4630 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC ## Overview - **Product Code:** FTC - **Device Name:** Light, Ultraviolet, Dermatological - **Regulation:** [21 CFR 878.4630](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4630) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K253871.md) | Klär Lite (RCW-KL1000) | Radcliffe Watts, LLC | Mar 4, 2026 | SESE | | [K250425](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K250425.md) | Ultraviolet Phototherapy Device | APK Technology Co., Ltd. | Apr 7, 2025 | SESE | | [K244022](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K244022.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K242977.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K242908.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K233811.md) | DT Controlled Phototherapy Equipment | Daavlin Distributing Co. | Dec 13, 2023 | SESE | | [K223882](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K223882.md) | Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) | Shenzhen Honpal Optoelectronic Technology Co., Ltd. | Mar 27, 2023 | SESE | | [K230382](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K230382.md) | 3 Series NeoLux | Daavlin Distributing Co. | Mar 24, 2023 | SESE | | [K230076](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K230076.md) | Enhanced AURORA™ Medical Diode System, and related accessories | Psoria-Shield, Inc. | Mar 8, 2023 | SESE | | [K220840](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K220840.md) | 1 Series Phototherapy Equipment | Daavlin Distributing Co. | Apr 22, 2022 | SESE | | [K210004](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K210004.md) | i8 Tanning Booth | Ultrasun International B.V. | Dec 10, 2021 | SESE | | [K212510](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K212510.md) | 7 Series Phototherapy Device | Daavlin Distributing Co. | Nov 4, 2021 | SESE | | [K210881](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K210881.md) | M Series Phototherapy Equipment | Daavlin Distributing Co. | Jun 22, 2021 | SESE | | [K202827](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K202827.md) | 308nm Excimer UV-light Skin Therapy System | Shenzhen Gsd Tech Co., Ltd. | Dec 15, 2020 | SESE | | [K200971](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K200971.md) | 308nm Excimer System | Xuzhou Kernel Medical Equipment Co., Ltd. | Dec 15, 2020 | SESE | | [K192411](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K192411.md) | Psoria-Shield AURORA | Psoria-Shield | Jul 2, 2020 | SESE | | [K192642](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K192642.md) | 308nm Excimer System | Chongqing Peninsula Medical Technology Co., Ltd. | May 13, 2020 | SESE | | [K191571](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K191571.md) | UV Radiation Treatment System | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Feb 6, 2020 | SESE | | [K191086](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K191086.md) | Exciplex | Clarteis | Dec 11, 2019 | SESE | | [K181805](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K181805.md) | 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 - Mottek Intl. Corp. — 8 clearances - Light Sources, Inc. — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com