510(k) Report

Devices descending from K100378

6 later devices reach 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210881M Series Phototherapy EquipmentDaavlin Distributing Co.202121
+1K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company201841
+1K1111724 Series Phototherapy Unit Model 4 SeriesDaavlin Distributing Co.201101
+2K2303823 Series NeoLuxDaavlin Distributing Co.20231—
+2K2125107 Series Phototherapy DeviceDaavlin Distributing Co.202101
+3K261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)Xuzhou Kernel Medical Equipment Co., Ltd.20260—