510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171227StarWalkerFotona D.O.O.20177—
+5K163196ACTION II Laser SystemLutronic Corporation20170—
+5K170269Hee HR MiniOriental Inspiration Limited201713—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+5K161089sensiLight MiniEl Global Trade, Ltd.20164—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K152790Venus Versa SystemVenus Concept, Ltd.20160—
+5K152714Quanta ForteQuanta System Spa201513—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152012EVO platformQuanta System Spa201537—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K150336Photonica ProfessionalWard Photonics, LLC20157—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K141868Tria FanpTria Beauty, Inc.20140—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+5K141242Glide DeviceHome Skinovations, Ltd.201419—
+5K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K133405MinnieElettronica Valseriana Srl20140—
+5K134017GigalaserPowermedic Aps20141—
+5K132976AdvatxAdvalight Aps20141—
+5K133837Viora V-TotalViora, Ltd.201433—
+5K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+5K131649MESyneron Beauty, Ltd.2013125—
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+5K132431Thermage CPT SystemSolta Medical, Inc.2013171
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K123845MESyneron Beauty, Ltd.2013126—
+5K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K120460SmartluxMedmix Co., Ltd.201218—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+5K111026ApolloPollogen, Ltd.201114—
+5K111784Venus Swan SystemVenus Concept, Ltd.20111—
+5K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110370Q-ClearLight Age, Inc.201135—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K102461FractoraInvasix, Ltd.201124—
+5K103455Spectra Laser SystemLutronic Corporation201192—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+5K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+5K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+5K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101321Ematrix CO2Syneron Medical, Ltd.20102—
+5K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+5K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+5K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+5K090724OR-LightYperion Technology20090—
+5K091534Lightlas Model 532Lightmed Corp.200972—
+5K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+5K090399Trios SystemViora, Ltd.20090—
+5K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K083595EzlaseBiolase Technology, Inc.200958—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+5K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+5K073000LumaprobeClareblend, Inc.20080—
+5K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+5K080638CLAROClrs Technology Corporation20082—