510(k) Report

Devices descending from K063808

34 later devices reach Fraxel IV SR Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+1K130459Tria Fan SystemTria Beauty, Inc.20131—
+1K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+1K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+1K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+2K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+2K230077LaserMENeauvia North America20232—
+2K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+2K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+2K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+2K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+2K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+2K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+2K192331LaseMD LEO Laser SystemLutronic Global20190—
+2K182173Joule SystemSciton, Inc20195—
+2K171009LASEMD Laser SystemLutronic Corporation20178—
+2K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+2K141868Tria FanpTria Beauty, Inc.20140—
+2K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+3K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K223727LavieenWontech Co., Ltd.20234—
+3K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+3K192856MT OneM&T S.R.L.20202—
+3K180406Ellipse YdunEllipse A/S20180—
+4K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+4K241406LavieenWontech Co., Ltd.20242—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+5K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+6K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—