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
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K192856MT OneM&T S.R.L.20202—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+5K171702Exciplex308nmClarteis20175—
+5K170970EpilaserEpilady 2000, LLC20172—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K170850Alma QAlma Lasers, Ltd.20172—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K161503ORIONYerim Engineering Co., Ltd.20161—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K160368EVO platformQuanta System Spa201636—
+5K142845SILKPRO laser hair removal systemWuhan Lotuxs Technology Co., Ltd.201511—
+5K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+5K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+5K140527Sensilight MiniEl Global Trade, Ltd.201423—
+5K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131649MESyneron Beauty, Ltd.2013125—
+5K130459Tria Fan SystemTria Beauty, Inc.20131—
+5K131870Glide DeviceHome Skinovations, Ltd.201333—
+5K130315Ipulse Hair Removal SystemCyden Limited2013124—
+5K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K122280Ipulse Smoothskin Hair Removal SystemCyden Limited2012125—
+5K121598ME HAIR2GOSyneron Medical, Ltd.2012127—
+5K120737Tria Laser Hair Removal SystemTria Beauty, Inc.2012130—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+5K113115Epicare YagLight Age, Inc.20120—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+5K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+5K110370Q-ClearLight Age, Inc.201135—
+5K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+5K103560Shaser Ipl Hair Removal SystemShaser, Inc.2011140—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+5K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+5K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+5K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+5K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K081578Accela SystemGenesis Biosystems, Inc.20080—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+5K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+5K072906SILK'NHome Skinovations, Ltd.2008169—
+5K072344Apl Medical SystemBios S.R.L.20076—
+5K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+5K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+5K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+5K070004AccentAlma Lasers, Ltd.2007181—
+5K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+5K061720CosmelightPenntack Enterprises, Inc.20070—
+5K063828Diomed Delta 25Diomed, Ltd.20075—
+5K063249BeamaxMedic Sharplight, Ltd.200758—
+5K063074Candela 3630 Laser SystemCandela Corp.2006179—
+5K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+5K062369Iridex Oculight TXIridex Corp200673—
+5K052354Oculase MDBiolase Technology, Inc.20065—
+5K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+5K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+5K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+5K060033Profile Multi-Platform SystemSciton, Inc2006221—
+5K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+5K053324Chromolite SystemChromogenex Plc200631—
+5K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—