510(k) Report

Devices descending from K991935

1,492 later devices reach Epilight Hair Removal System, Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+3K161089sensiLight MiniEl Global Trade, Ltd.20164—
+3K153229SuperbiumBios S.R.L.20162—
+3K153717Venus Versa SystemVenus Concept, Ltd.20161—
+3K152790Venus Versa SystemVenus Concept, Ltd.20160—
+3K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K150336Photonica ProfessionalWard Photonics, LLC20157—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K141242Glide DeviceHome Skinovations, Ltd.201419—
+3K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+3K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+3K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+3K134017GigalaserPowermedic Aps20141—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K131649MESyneron Beauty, Ltd.2013125—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+3K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+3K123845MESyneron Beauty, Ltd.2013126—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K120460SmartluxMedmix Co., Ltd.201218—
+3K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+3K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+3K113115Epicare YagLight Age, Inc.20120—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K110370Q-ClearLight Age, Inc.201135—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+3K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+3K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K090724OR-LightYperion Technology20090—
+3K090762LEDAQuantel Derma GmbH200946—
+3K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+3K090399Trios SystemViora, Ltd.20090—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+3K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+3K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+3K073000LumaprobeClareblend, Inc.20080—
+3K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+3K080638CLAROClrs Technology Corporation20082—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K073477Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB20083—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080318Alma Laser Nir ModuleAlma Lasers, Ltd.2008184—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070004AccentAlma Lasers, Ltd.2007181—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K063249BeamaxMedic Sharplight, Ltd.200758—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd.20063—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+3K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+3K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+3K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K053324Chromolite SystemChromogenex Plc200631—