510(k) Report

Devices descending from K130193

25 later devices reach Fraxel Dual 1550/1927 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+1K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+1K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+1K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+1K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+1K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+1K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+1K192331LaseMD LEO Laser SystemLutronic Global20190—
+1K182173Joule SystemSciton, Inc20195—
+1K171009LASEMD Laser SystemLutronic Corporation20178—
+1K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+2K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+2K223727LavieenWontech Co., Ltd.20234—
+2K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+2K192856MT OneM&T S.R.L.20202—
+2K180406Ellipse YdunEllipse A/S20180—
+3K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+3K241406LavieenWontech Co., Ltd.20242—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+4K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+5K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—