510(k) Report

Devices descending from K011092

1,127 later devices reach Candela SPTL-1E Pulsed Dye Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+1K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002699—
+1K013043Candela Clearbeam Pulsed Dye LaserCandela Corp.2001703—
+2K151337StrialiteCentre Light Solutions, LLC20160—
+2K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+2K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+2K081578Accela SystemGenesis Biosystems, Inc.20080—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K061720CosmelightPenntack Enterprises, Inc.20070—
+2K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+2K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+2K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+2K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+2K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+2K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+2K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+2K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+2K032460Profile BBL SystemSciton, Inc2003569—
+2K031489PitangaSyneron Medical, Ltd.20030—
+2K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+2K030426Omnilux RedPhoto Therapeutics Limited2003563—
+2K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+2K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+2K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp.2002318—
+2K020958Candela Cbeam Pulsed Dye Laser SystemCandela Corp.2002231—
+2K020729Nlite System,Model A00-1051Icn Photonics, Ltd.20023—
+3K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K162851eLyx-PROIntelligent Sensory Concept SA20170—
+3K153229SuperbiumBios S.R.L.20162—
+3K141237Harmony LiteAlma, Inc.20154—
+3K150336Photonica ProfessionalWard Photonics, LLC20157—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+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—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K120460SmartluxMedmix Co., Ltd.201218—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K110370Q-ClearLight Age, Inc.201135—
+3K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+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—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+3K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+3K090762LEDAQuantel Derma GmbH200946—
+3K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+3K090399Trios SystemViora, Ltd.20090—
+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—
+3K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+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—
+3K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K063800Candela Fluorescent Pulsed Light SystemCandela Corp.20070—
+3K060792IllumimedPhotoactif, LLC2006115—
+3K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl20060—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+3K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+3K060516Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S200612—
+3K052371Depilite EL-8B Series Dermo Flash SystemsHair International Systems USA, Inc.20060—
+3K060567Spectragenics Ats-1Spectragenics, Inc.20062—
+3K060216Energist Ultra VPL Intense Pulse Light SystemEnergist, Ltd.20060—
+3K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc20068—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K052991Radiancy Facial Skincare DeviceRadiancy (Israel), Ltd.20060—