510(k) K250425

Device
Ultraviolet Phototherapy Device
Applicant
APK Technology Co., Ltd.
510(k) number
K250425
Product code
FTC
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-07
Date received
2025-02-14
Regulation
878.4630
Classification name
Light, Ultraviolet, Dermatological
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Caifang Wang
Address
6 Floor, Bldg. B2, Industry Of Hengfeng, # 739, Zhoushi Hezhou, Hangcheng St., Bao’An District Shenzhen CN 518100 518100

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Related GUDID Devices

Primary DIBrandCompanyPublished
06946725599990APKAPK Technology Co.,Ltd.2025-09-22

Other 510(k) Records For Product Code FTC

510(k)DeviceApplicantDecision date
K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.2026-05-01
K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC2026-03-04
K244022308nm 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.2025-03-13
K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.2025-02-06
K242908UV 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.2024-12-19
K233811DT Controlled Phototherapy EquipmentDaavlin Distributing Co.2023-12-13
K223882Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)Shenzhen Honpal Optoelectronic Technology Co., Ltd.2023-03-27
K2303823 Series NeoLuxDaavlin Distributing Co.2023-03-24
K230076Enhanced AURORA™ Medical Diode System, and related accessoriesPsoria-Shield, Inc.2023-03-08
K2208401 Series Phototherapy EquipmentDaavlin Distributing Co.2022-04-22
K210004i8 Tanning BoothUltrasun International B.V.2021-12-10
K2125107 Series Phototherapy DeviceDaavlin Distributing Co.2021-11-04
K210881M Series Phototherapy EquipmentDaavlin Distributing Co.2021-06-22
K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.2020-12-15
K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.2020-12-15