510(k) Report

Devices descending from K020839

1,046 later devices reach Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+1K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+1K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+1K081578Accela SystemGenesis Biosystems, Inc.20080—
+1K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+1K061720CosmelightPenntack Enterprises, Inc.20070—
+1K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+1K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+1K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+1K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+1K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+1K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+1K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+1K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+1K032460Profile BBL SystemSciton, Inc2003569—
+1K031489PitangaSyneron Medical, Ltd.20030—
+1K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+1K030426Omnilux RedPhoto Therapeutics Limited2003563—
+1K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+1K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+1K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+2K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+2K233024Alma HarmonyAlma Lasers, Inc.20241—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+2K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+2K200104OxylightRaja Trading Company, Inc.202024—
+2K192856MT OneM&T S.R.L.20202—
+2K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+2K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+2K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+2K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+2K162851eLyx-PROIntelligent Sensory Concept SA20170—
+2K153229SuperbiumBios S.R.L.20162—
+2K141237Harmony LiteAlma, Inc.20154—
+2K150336Photonica ProfessionalWard Photonics, LLC20157—
+2K142860Lumenis M22 SystemLumenis, Ltd.2015381
+2K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+2K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+2K134017GigalaserPowermedic Aps20141—
+2K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+2K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+2K120460SmartluxMedmix Co., Ltd.201218—
+2K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+2K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+2K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+2K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+2K092734E-Light LineEspansione Marketing S.P.A20102—
+2K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+2K093465Fusion SystemEclipsemed Global, Inc.20100—
+2K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+2K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+2K090762LEDAQuantel Derma GmbH200946—
+2K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+2K090399Trios SystemViora, Ltd.20090—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+2K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+2K081408Ellipse MultiflexEllipse A/S20087—
+2K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+2K073000LumaprobeClareblend, Inc.20080—
+2K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+2K080638CLAROClrs Technology Corporation20082—
+2K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+2K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+2K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+2K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+2K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+2K060792IllumimedPhotoactif, LLC2006115—
+2K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+2K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+2K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+2K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+2K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+2K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+2K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+2K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+2K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—
+2K052688Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S200523—
+2K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+2K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+2K043032Dealight IplEuropro, Inc.20050—
+2K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+2K051255Lumiphase-ROpusmed, Inc.2005143—
+2K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+2K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+2K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+2K033946Lovely SystemMsq (M2), Ltd.2004737—
+2K040156Ifl Professional System, Model C100Cyden Limited20040—
+2K033933Powerlite 600 EX SystemPreswede AB20040—
+3K252561BTL-754FFBTL Industries, Inc.20260—
+3K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+3K231948MediyagMedicreations, LLC20240—