510(k) Report

Devices descending from K980517

1,509 later devices reach Epilaser Normal Mode Ruby Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+4K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin ProHome Well Trading, Ltd.20180—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K180224Element-TLElemenic Co., Ltd.20180—
+4K173285Joule SystemSciton, Inc20185—
+4K172181micro IPLEl Global Trade, Ltd.20170—
+4K170850Alma QAlma Lasers, Ltd.20172—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K170269Hee HR MiniOriental Inspiration Limited201713—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162851eLyx-PROIntelligent Sensory Concept SA20170—
+4K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co.,Ltd201619—
+4K161089sensiLight MiniEl Global Trade, Ltd.20164—
+4K153229SuperbiumBios S.R.L.20162—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K152790Venus Versa SystemVenus Concept, Ltd.20160—
+4K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K141242Glide DeviceHome Skinovations, Ltd.201419—
+4K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+4K134017GigalaserPowermedic Aps20141—
+4K132976AdvatxAdvalight Aps20141—
+4K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+4K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+4K131649MESyneron Beauty, Ltd.2013125—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130199Clarity LPC Laser SystemLutronic Corporation20135—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K132266Shaser HRS2 RX Hair Removal SystemShaser, Inc.201397—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K123845MESyneron Beauty, Ltd.2013126—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K120460SmartluxMedmix Co., Ltd.201218—
+4K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113115Epicare YagLight Age, Inc.20120—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110370Q-ClearLight Age, Inc.201135—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+4K090724OR-LightYperion Technology20090—
+4K090762LEDAQuantel Derma GmbH200946—
+4K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+4K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K090399Trios SystemViora, Ltd.20090—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+4K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+4K073000LumaprobeClareblend, Inc.20080—
+4K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+4K080638CLAROClrs Technology Corporation20082—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+4K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+4K073477Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB20083—