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FTC — Light, Ultraviolet, Dermatological Class II

FDA Device Classification

Classification Details

Product Code
FTC
Device Class
Class II
Regulation Number
878.4630
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253871radcliffe wattsKlär Lite (RCW-KL1000)March 4, 2026
K250425apk technology coUltraviolet Phototherapy DeviceApril 7, 2025
K244022boston aesthetics308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm March 13, 2025
K242977xuzhou kernel medical equipment co308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-50February 6, 2025
K242908shanghai sigma high-tech coUV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD,December 19, 2024
K233811daavlin distributingDT Controlled Phototherapy EquipmentDecember 13, 2023
K223882shenzhen honpal optoelectronic technology coNarrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)March 27, 2023
K230382daavlin distributing3 Series NeoLuxMarch 24, 2023
K230076psoria-shieldEnhanced AURORA™ Medical Diode System, and related accessoriesMarch 8, 2023
K220840daavlin distributing1 Series Phototherapy EquipmentApril 22, 2022
K210004ultrasun internationali8 Tanning BoothDecember 10, 2021
K212510daavlin distributing7 Series Phototherapy DeviceNovember 4, 2021
K210881daavlin distributingM Series Phototherapy EquipmentJune 22, 2021
K202827shenzhen gsd tech co308nm Excimer UV-light Skin Therapy SystemDecember 15, 2020
K200971xuzhou kernel medical equipment co308nm Excimer SystemDecember 15, 2020
K192411psoria-shieldPsoria-Shield AURORAJuly 2, 2020
K192642chongqing peninsula medical technology co308nm Excimer SystemMay 13, 2020
K191571xuzhou yongkang electronic science technology coUV Radiation Treatment SystemFebruary 6, 2020
K191086clarteisExciplexDecember 11, 2019
K181805xuzhou kernel medical equipment coUV PhototherapyJanuary 11, 2019