510(k) Report

Devices descending from K150752

9 later devices reach GME ExSys 308 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—
+1K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+1K171702Exciplex308nmClarteis20175—
+2K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+2K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+2K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+2K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+2K191086ExciplexClarteis20194—
+3K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—