FTC · Light, Ultraviolet, Dermatological

Device class

Class II

Regulation 878.4630

Total clearances

2020-02-06 → 2026-05-01

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4630

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Daavlin Distributing Co.	5	0	2023-12-13
Psoria-Shield, Inc.	2	0	2023-03-08
Xuzhou Kernel Medical Equipment Co., Ltd.	2	0	2025-02-06
Choyang Medics Co., Ltd.	1	1	2026-05-01
Chongqing Peninsula Medical Technology Co., Ltd.	1	0	2020-05-13
Ultrasun International B.V.	1	0	2021-12-10
Boston Aesthetics, Inc.	1	0	2025-03-13
Radcliffe Watts, LLC	1	1	2026-03-04
Xuzhou Yongkang Electronic Science Technology Co., Ltd.	1	0	2020-02-06
Shenzhen Honpal Optoelectronic Technology Co., Ltd.	1	0	2023-03-27
APK Technology Co., Ltd.	1	0	2025-04-07
Shanghai Sigma High-Tech Co., Ltd.	1	0	2024-12-19
Shenzhen Gsd Tech Co., Ltd.	1	0	2020-12-15

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
96912	CPT	—	High	Photochemotherapy (including UV light therapy) for dermatological use
E0691	HCPCS	Ultraviolet light therapy system, includes bulbs/lamps, timer and eye protection; treatment area 2 square feet or less ✓ CMS-verified description	Medium	UV light therapy equipment rental code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-01	K254234	Choyang Medics Co., Ltd.	Phototherapy System (DUV-COMBO)
2026-03-04	K253871	Radcliffe Watts, LLC	Klär Lite (RCW-KL1000)
2025-04-07	K250425	APK Technology Co., Ltd.	Ultraviolet Phototherapy Device
2025-03-13	K244022	Boston Aesthetics, Inc.	308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
2025-02-06	K242977	Xuzhou Kernel Medical Equipment Co., Ltd.	308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
2024-12-19	K242908	Shanghai Sigma High-Tech Co., Ltd.	UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
2023-12-13	K233811	Daavlin Distributing Co.	DT Controlled Phototherapy Equipment
2023-03-27	K223882	Shenzhen Honpal Optoelectronic Technology Co., Ltd.	Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
2023-03-24	K230382	Daavlin Distributing Co.	3 Series NeoLux
2023-03-08	K230076	Psoria-Shield, Inc.	Enhanced AURORA Medical Diode System, and related accessories
2022-04-22	K220840	Daavlin Distributing Co.	1 Series Phototherapy Equipment
2021-12-10	K210004	Ultrasun International B.V.	i8 Tanning Booth
2021-11-04	K212510	Daavlin Distributing Co.	7 Series Phototherapy Device
2021-06-22	K210881	Daavlin Distributing Co.	M Series Phototherapy Equipment
2020-12-15	K202827	Shenzhen Gsd Tech Co., Ltd.	308nm Excimer UV-light Skin Therapy System
2020-12-15	K200971	Xuzhou Kernel Medical Equipment Co., Ltd.	308nm Excimer System
2020-07-02	K192411	Psoria-Shield	Psoria-Shield AURORA
2020-05-13	K192642	Chongqing Peninsula Medical Technology Co., Ltd.	308nm Excimer System
2020-02-06	K191571	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	UV Radiation Treatment System