510(k) Report

Devices descending from K191086

4 later devices reach Exciplex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+1K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+2K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+3K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—