510(k) Report

Devices descending from K910422

1,503 later devices reach Model RD-1200 Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+6K172181micro IPLEl Global Trade, Ltd.20170—
+6K172413MT ONEM&T S.R.L.20175—
+6K171227StarWalkerFotona D.O.O.20177—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K170269Hee HR MiniOriental Inspiration Limited201713—
+6K162851eLyx-PROIntelligent Sensory Concept SA20170—
+6K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+6K161089sensiLight MiniEl Global Trade, Ltd.20164—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K152790Venus Versa SystemVenus Concept, Ltd.20160—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152012EVO platformQuanta System Spa201537—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+6K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+6K141975Waterlase Iplus SBiolase, Inc.20150—
+6K150336Photonica ProfessionalWard Photonics, LLC20157—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K141868Tria FanpTria Beauty, Inc.20140—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+6K141242Glide DeviceHome Skinovations, Ltd.201419—
+6K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+6K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+6K133405MinnieElettronica Valseriana Srl20140—
+6K134017GigalaserPowermedic Aps20141—
+6K132976AdvatxAdvalight Aps20141—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K131649MESyneron Beauty, Ltd.2013125—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+6K132431Thermage CPT SystemSolta Medical, Inc.2013171
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K123845MESyneron Beauty, Ltd.2013126—
+6K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K120460SmartluxMedmix Co., Ltd.201218—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+6K111026ApolloPollogen, Ltd.201114—
+6K111784Venus Swan SystemVenus Concept, Ltd.20111—
+6K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K110370Q-ClearLight Age, Inc.201135—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K102461FractoraInvasix, Ltd.201124—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+6K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+6K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+6K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+6K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+6K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc.2010124—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+6K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+6K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+6K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+6K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+6K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+6K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+6K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+6K090724OR-LightYperion Technology20090—
+6K091534Lightlas Model 532Lightmed Corp.200972—
+6K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+6K090399Trios SystemViora, Ltd.20090—
+6K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+6K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+6K083595EzlaseBiolase Technology, Inc.200958—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871