510(k) Report

Devices descending from K080915

187 later devices reach Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091115ECO2 Laser SystemLutronic Corporation200927—
+1K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+1K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+2K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+2K123573Youlaser CO2 LaserQuanta System Spa201319—
+2K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+2K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+2K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K244060eCO2 3DLutronic Corporation20250—
+3K182669Youlaser CO2Quanta System Spa20181—
+3K173285Joule SystemSciton, Inc20185—
+3K160312Fraxis DuoIlooda Co,., Ltd.201614—
+3K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+3K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+3K150027CYMAWhitecap Technologies, LLC20150—
+3K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+4K233473Deka LotusEl.En S.P.A.20241—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K192856MT OneM&T S.R.L.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+4K180508Joule SystemSciton, Inc20183—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+4K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+4K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K250281Deka LotusEl.En S.P.A.20250—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K241270BTL-754BTL Industries, Inc.20251—
+5K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230077LaserMENeauvia North America20232—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K210084SilkroHironic Co., Ltd.20223—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K233123SilkroHironic Co., Ltd.20241—
+6K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+6K233099GladiatorRohrer Aesthetics, LLC20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+6K233147PiXel8-RFRohrer Aesthetics20230—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K211000AcutronIlooda Co,., Ltd.20220—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—