510(k) Report

Devices descending from K972767

1,179 later devices reach Candela Gentlelase GL Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213261EpilMENeauvia North America20220—
+5K213350mJOULE System and AccessoriesSciton, Inc20220—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K201111GentleMax Pro PlusCandela Corporation20203—
+5K192856MT OneM&T S.R.L.20202—
+5K200110SANDRO DualWontech Co., Ltd.20202—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K193426Elite iQCynosure, LLC20201—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K183452Vbeam Prima Laser SystemCandela Corp.20191—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K180224Element-TLElemenic Co., Ltd.20180—
+5K173285Joule SystemSciton, Inc20185—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+5K153229SuperbiumBios S.R.L.20162—
+5K152012EVO platformQuanta System Spa201537—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K150336Photonica ProfessionalWard Photonics, LLC20157—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+5K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+5K134017GigalaserPowermedic Aps20141—
+5K132976AdvatxAdvalight Aps20141—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+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—
+5K120460SmartluxMedmix Co., Ltd.201218—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K110370Q-ClearLight Age, Inc.201135—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+5K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+5K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+5K090762LEDAQuantel Derma GmbH200946—
+5K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+5K090399Trios SystemViora, Ltd.20090—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+5K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+5K090618Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo CCynosure, Inc.20090—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K081408Ellipse MultiflexEllipse A/S20087—
+5K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+5K073000LumaprobeClareblend, Inc.20080—
+5K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+5K080638CLAROClrs Technology Corporation20082—
+5K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+5K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+5K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+5K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+5K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+5K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+5K060792IllumimedPhotoactif, LLC2006115—
+5K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+5K062369Iridex Oculight TXIridex Corp200673—
+5K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+5K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+5K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+5K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+5K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+5K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+5K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+5K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+5K052310Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG20060—
+5K060033Profile Multi-Platform SystemSciton, Inc2006221—
+5K060395Cryo, Model V6.0Zimmer Elektromedizin GmbH20069—
+5K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+5K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—