510(k) Report

Devices descending from K170489

5 later devices reach Skylit Phototherapy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC20260—
+1K173436Luma Light SystemLuma Therapeutics20183—
+2K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+3K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+4K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—