510(k) Report

Devices descending from K022104

17 later devices reach Dermapal, Uva 50HZ, Uva 60HZ, Uvb Broad Band 50HZ, Uvb Broad Band 60HZ,Uvb… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073587Dermapal with Digital TimerDaavlin Distributing Co.200816—
+2K233811DT Controlled Phototherapy EquipmentDaavlin Distributing Co.20230—
+2K170489Skylit Phototherapy SystemSkylit Medical20175—
+2K1003781 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co.201061
+2K090097LH-75T Phototherapy SystemLerner Medical Devices, Inc.20097—
+3K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+3K210881M Series Phototherapy EquipmentDaavlin Distributing Co.202121
+3K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company201841
+3K173436Luma Light SystemLuma Therapeutics20183—
+3K1111724 Series Phototherapy Unit Model 4 SeriesDaavlin Distributing Co.201101
+3K091568LH-75 Phototherapy SystemLerner Medical Devices, Inc.20090—
+4K2303823 Series NeoLuxDaavlin Distributing Co.20231—
+4K2125107 Series Phototherapy DeviceDaavlin Distributing Co.202101
+4K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd.20260—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—