510(k) Report

Devices descending from K955612

1,548 later devices reach RD-1200H Normal Mode Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+6K180508Joule SystemSciton, Inc20183—
+6K180224Element-TLElemenic Co., Ltd.20180—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K173285Joule SystemSciton, Inc20185—
+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—
+6K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+6K171227StarWalkerFotona D.O.O.20177—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K170269Hee HR MiniOriental Inspiration Limited201713—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+6K162851eLyx-PROIntelligent Sensory Concept SA20170—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+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—
+6K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+6K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+6K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+6K141975Waterlase Iplus SBiolase, Inc.20150—
+6K150336Photonica ProfessionalWard Photonics, LLC20157—
+6K141868Tria FanpTria Beauty, Inc.20140—
+6K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+6K141555AdvantageLutronic Corporation201414—
+6K141242Glide DeviceHome Skinovations, Ltd.201419—
+6K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+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—
+6K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+6K133405MinnieElettronica Valseriana Srl20140—
+6K134017GigalaserPowermedic Aps20141—
+6K132976AdvatxAdvalight Aps20141—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+6K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K130199Clarity LPC Laser SystemLutronic Corporation20135—
+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—
+6K122493GenesisplusCutera, Inc.201318—
+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—
+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—
+6K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+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—
+6K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+6K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+6K111483Joule Clearsense Laser SystemSciton, Inc20110—
+6K111026ApolloPollogen, Ltd.201114—
+6K111784Venus Swan SystemVenus Concept, Ltd.20111—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+6K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+6K102461FractoraInvasix, Ltd.201124—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+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—
+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—