510(k) Report

Devices descending from K053047

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+1K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+1K070392Mosaic Laser SystemLutronic Corporation20078—
+1K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+2K101321Ematrix CO2Syneron Medical, Ltd.20102—
+2K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+2K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+2K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+2K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+2K080932Mosaic Laser SystemLutronic Corporation20086—
+3K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+3K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+3K151655CO2RE SystemSyneron Medical, Ltd.20151—
+3K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+3K132754Neogen PSR SystemEnergist, Ltd.20132—
+3K123573Youlaser CO2 LaserQuanta System Spa201319—
+3K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+3K091115ECO2 Laser SystemLutronic Corporation200927—
+3K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+3K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K221873NeoGen PSR SystemEnergist Limited20230—
+4K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+4K192856MT OneM&T S.R.L.20202—
+4K182669Youlaser CO2Quanta System Spa20181—
+4K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+4K180406Ellipse YdunEllipse A/S20180—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+4K150027CYMAWhitecap Technologies, LLC20150—
+4K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K244060eCO2 3DLutronic Corporation20250—
+5K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K173285Joule SystemSciton, Inc20185—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K210084SilkroHironic Co., Ltd.20223—
+6K193656SkyPulseFotona D.O.O.202011—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K180508Joule SystemSciton, Inc20183—
+6K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+6K153229SuperbiumBios S.R.L.20162—
+6K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+7K252561BTL-754FFBTL Industries, Inc.20260—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K250189AdvaTxAdvalight Aps20250—
+7K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+7K250281Deka LotusEl.En S.P.A.20250—
+7K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+7K241270BTL-754BTL Industries, Inc.20251—
+7K233123SilkroHironic Co., Ltd.20241—
+7K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+7K233099GladiatorRohrer Aesthetics, LLC20240—
+7K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+7K233143PiXel8-RevealRohrer Aesthetics20240—
+7K233147PiXel8-RFRohrer Aesthetics20230—
+7K230077LaserMENeauvia North America20232—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K193426Elite iQCynosure, LLC20201—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+7K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+7K141237Harmony LiteAlma, Inc.20154—