510(k) Report

Devices descending from K073066

6 later devices reach 308 Dermatological Excimer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171702Exciplex308nmClarteis20175—
+2K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+2K191086ExciplexClarteis20194—
+3K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+4K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—