FDA Product Code FTC: Light, Ultraviolet, Dermatological
Leading manufacturers include National Biological Corp., Daavlin Distributing Co. and Xuzhou Kernel Medical Equipment Co., Ltd..
272
Total
272
Cleared
77d
Avg days
1976
Since
Growing category -
6 submissions in the last 2 years
vs 4 in the prior period
Review times increasing: avg
93d
recently vs 76d historically
FDA 510(k) Cleared Light, Ultraviolet, Dermatological Devices (Product Code FTC)
272 devices
Cleared
May 01, 2026
Phototherapy System (DUV-COMBO)
Choyang Medics Co., Ltd.
General & Plastic Surgery
123d
Cleared
Mar 04, 2026
Klär Lite (RCW-KL1000)
Radcliffe Watts, LLC
General & Plastic Surgery
90d
Cleared
Apr 07, 2025
Ultraviolet Phototherapy Device
APK Technology Co., Ltd.
General & Plastic Surgery
52d
Cleared
Mar 13, 2025
308nm UV Phototherapy System (UV-K)
Boston Aesthetics, Inc.
General & Plastic Surgery
76d
Cleared
Feb 06, 2025
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
Xuzhou Kernel Medical Equipment Co., Ltd.
General & Plastic Surgery
133d
Cleared
Dec 19, 2024
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD)
Shanghai Sigma High-Tech Co., Ltd.
General & Plastic Surgery
86d
Cleared
Dec 13, 2023
DT Controlled Phototherapy Equipment
Daavlin Distributing Co.
General & Plastic Surgery
14d
Cleared
Mar 27, 2023
Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
Shenzhen Honpal Optoelectronic Technology Co., Ltd.
General & Plastic Surgery
90d
Cleared
Mar 24, 2023
3 Series NeoLux
Daavlin Distributing Co.
General & Plastic Surgery
39d
Cleared
Mar 08, 2023
Enhanced AURORA™ Medical Diode System, and related accessories
Psoria-Shield, Inc.
General & Plastic Surgery
57d
Cleared
Apr 22, 2022
1 Series Phototherapy Equipment
Daavlin Distributing Co.
General & Plastic Surgery
30d
Cleared
Dec 10, 2021
i8 Tanning Booth
Ultrasun International B.V.
General & Plastic Surgery
340d
Cleared
Nov 04, 2021
7 Series Phototherapy Device
Daavlin Distributing Co.
General & Plastic Surgery
86d
Cleared
Jun 22, 2021
M Series Phototherapy Equipment
Daavlin Distributing Co.
General & Plastic Surgery
89d
Cleared
Dec 15, 2020
308nm Excimer System
Xuzhou Kernel Medical Equipment Co., Ltd.
General & Plastic Surgery
246d
Cleared
Dec 15, 2020
308nm Excimer UV-light Skin Therapy System
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery
82d
Cleared
Jul 02, 2020
Psoria-Shield AURORA
Psoria-Shield
General & Plastic Surgery
302d
Cleared
May 13, 2020
308nm Excimer System
Chongqing Peninsula Medical Technology Co., Ltd.
General & Plastic Surgery
232d
Cleared
Feb 06, 2020
UV Radiation Treatment System
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
General & Plastic Surgery
237d
Cleared
Dec 11, 2019
Exciplex
Clarteis
General & Plastic Surgery
231d
Cleared
Jan 11, 2019
UV Phototherapy
Xuzhou Kernel Medical Equipment Co., Ltd.
General & Plastic Surgery
189d
Cleared
Oct 29, 2018
ClearLink Controlled Phototherapy Equipment
Daavlin Distributing Company
General & Plastic Surgery
75d
Cleared
Jul 30, 2018
308nm Excimer System
Chongqing Peninsula Medical Technology Co., Ltd.
General & Plastic Surgery
367d
Cleared
Jan 30, 2018
Luma Light System
Luma Therapeutics
General & Plastic Surgery
88d
About Product Code FTC - Regulatory Context
510(k) Submission Activity
272 total 510(k) submissions under product code FTC since 1976, with 272 receiving FDA clearance (average review time: 77 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - FTC Product Code
Recent submissions under FTC have taken an average of 93 days to reach a decision - up from 76 days historically. Manufacturers should account for longer review timelines in current project planning.
FTC devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →