510(k) Report

Devices descending from K091420

62 later devices reach Fraxel RE: Store Laser System, Model SR1500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130459Tria Fan SystemTria Beauty, Inc.20131—
+1K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+1K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+2K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+2K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+2K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K141868Tria FanpTria Beauty, Inc.20140—
+2K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+2K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+3K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+3K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+3K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+3K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+3K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+3K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+3K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+3K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+3K200616E>EyeCE-Swin20200—
+3K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+3K192856MT OneM&T S.R.L.20202—
+3K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K192331LaseMD LEO Laser SystemLutronic Global20190—
+3K182173Joule SystemSciton, Inc20195—
+3K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+3K180406Ellipse YdunEllipse A/S20180—
+3K171009LASEMD Laser SystemLutronic Corporation20178—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+4K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+4K250809Stellar M22Lumenis Be, Ltd.20250—
+4K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K234057NirvanaEl.En S.P.A.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K223727LavieenWontech Co., Ltd.20234—
+4K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+4K222790F65 Laser SystemLumenis Be, Ltd.20233—
+4K222221Deka HelixEl.En Electronic Engineering Spa20231—
+4K22079410PLTentech Co., Ltd.20220—
+4K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K162781Magma SparkFormatk Systems, Ltd.20160—
+5K252723Dynamis Pro FamilyFotona D.O.O.20260—
+5K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251919Thulium Laser System (Deluxlase)Nanjing Bestview Laser S&T Co., Ltd.20250—
+5K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+5K242349FoLixLumenis Be, Ltd.20240—
+5K241406LavieenWontech Co., Ltd.20242—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+6K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+7K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—