FDA Product Code FTC: Light, Ultraviolet, Dermatological
Leading manufacturers include Daavlin Distributing Co., Xuzhou Kernel Medical Equipment Co., Ltd. and Chongqing Peninsula Medical Technology 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 →