510(k) Report

Devices descending from K020839

1,046 later devices reach Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+3K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+3K233473Deka LotusEl.En S.P.A.20241—
+3K234057NirvanaEl.En S.P.A.20240—
+3K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+3K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+3K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+3K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+3K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+3K22079410PLTentech Co., Ltd.20220—
+3K212790XLase PlusBiotec Italia, Srl20220—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K203728DarwinLuvo Medical Technologies, Inc.20211—
+3K203054FlexSysGme German Medical Engineering GmbH20210—
+3K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+3K202172StarWalkerFotona D.O.O.20203—
+3K200616E>EyeCE-Swin20200—
+3K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+3K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+3K193656SkyPulseFotona D.O.O.202011—
+3K191693BC-5Reveallux, Corp20190—
+3K183708Poly ClearMedtek Skincare, LLC201922—
+3K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+3K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+3K180508Joule SystemSciton, Inc20183—
+3K173285Joule SystemSciton, Inc20185—
+3K172413MT ONEM&T S.R.L.20175—
+3K171227StarWalkerFotona D.O.O.20177—
+3K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+3K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+3K163196ACTION II Laser SystemLutronic Corporation20170—
+3K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+3K160880Photonica ProfessionalWard Photonics, LLC20166—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K153566Magma SystemFormatk Systems, Ltd.20162—
+3K153717Venus Versa SystemVenus Concept, Ltd.20161—
+3K153081Clear Bi-LightMichael Todd, LP201646—
+3K152790Venus Versa SystemVenus Concept, Ltd.20160—
+3K152714Quanta ForteQuanta System Spa201513—
+3K152012EVO platformQuanta System Spa201537—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+3K140386Lumina 24Rogers Sciences, Inc.20150—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+3K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+3K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K124064Young AgainEspansione Marketing S.P.A20131—
+3K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+3K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+3K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K121435Silkn BlueHome Skinovations, Ltd.2013125—
+3K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+3K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+3K122237Biophotas LifelightBiophotas, Inc.201371—
+3K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K111286Quasar CalypsoSilver Bay, LLC201276—
+3K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+3K110301Silk'n FXHome Skinovations, Ltd.201166—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+3K103415Tanda MaxPharos Life Corporation20110—
+3K100628PlasmaluxlsDaavlin Distributing Co.20100—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K091467Baby QuasarSilver Bay, LLC20100—
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K093168Mediflash and EsteflashDermeo20100—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K090744CLAROClrs Technology Corporation20101—
+3K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+3K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+3K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+3K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+3K090724OR-LightYperion Technology20090—
+3K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K083730IsolazAesthera Corporation20093—