510(k) Report

Devices descending from K050841

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130459Tria Fan SystemTria Beauty, Inc.20131—
+1K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+1K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+1K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+1K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+1K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+1K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+1K053047Fraxel SR Laser SystemReliant Technologies, Inc.2006205—
+2K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+2K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+2K141868Tria FanpTria Beauty, Inc.20140—
+2K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+2K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+2K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K101321Ematrix CO2Syneron Medical, Ltd.20102—
+2K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+2K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+2K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+2K090525Loi SystemPalomar Medical Products, Inc.20099—
+2K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+2K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+2K080932Mosaic Laser SystemLutronic Corporation20086—
+2K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+2K070392Mosaic Laser SystemLutronic Corporation20078—
+3K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+3K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+3K230077LaserMENeauvia North America20232—
+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—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+3K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+3K193656SkyPulseFotona D.O.O.202011—
+3K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+3K192331LaseMD LEO Laser SystemLutronic Global20190—
+3K182173Joule SystemSciton, Inc20195—
+3K173285Joule SystemSciton, Inc20185—
+3K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+3K171009LASEMD Laser SystemLutronic Corporation20178—
+3K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+3K153229SuperbiumBios S.R.L.20162—
+3K151655CO2RE SystemSyneron Medical, Ltd.20151—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+3K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+3K123573Youlaser CO2 LaserQuanta System Spa201319—
+3K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+3K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K091115ECO2 Laser SystemLutronic Corporation200927—
+3K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K223727LavieenWontech Co., Ltd.20234—
+4K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222685NIRA Model 2Dermal Photonics Corp20230—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K192856MT OneM&T S.R.L.20202—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182669Youlaser CO2Quanta System Spa20181—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K180508Joule SystemSciton, Inc20183—
+4K180406Ellipse YdunEllipse A/S20180—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K150027CYMAWhitecap Technologies, LLC20150—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+4K132754Neogen PSR SystemEnergist, Ltd.20132—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—