510(k) Report

Devices descending from K950661

1,153 later devices reach Candela 10MM Circular Spot Laser Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K960032Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group19961,152—
+2K050738FT Fiber Optic Delivery SystemsFibertech GmbH20052255
+2K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.20021,046—
+2K980389Megabeam Reusable Fiber Optic Handpiece and NeedlesCeram Optec, Inc.19983—
+2K974633Scantech Laser ScannerPhantom Technologies, Inc.19980—
+2K972915Erbium 2000 Laser FamilyPhantom Technologies, Inc.19970—
+2K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc.19971,142—
+3K140366Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC20141—
+3K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K111350Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc.20110—
+3K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+3K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+3K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC20081591
+3K081578Accela SystemGenesis Biosystems, Inc.20080—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K061720CosmelightPenntack Enterprises, Inc.20070—
+3K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+3K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc.20061—
+3K060905Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp20060—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+3K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+3K043255Ellipse Light SPTDanish Dermatologic Development A/S200525—
+3K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+3K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+3K032460Profile BBL SystemSciton, Inc2003569—
+3K031489PitangaSyneron Medical, Ltd.20030—
+3K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+3K030426Omnilux RedPhoto Therapeutics Limited2003563—
+3K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+3K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+3K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+3K001589Candela Dynamic Cooling DeviceCandela Corp.20001,064—
+3K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700—
+4K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+4K163197Cook Holmium Laser FiberCook Incorporated20170—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162851eLyx-PROIntelligent Sensory Concept SA20170—
+4K152667ATOVEN-Reusable Laser FiberDiotech CO20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153564Pure CryogenAir Liquide Healthcare America Corporation20160—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+4K134017GigalaserPowermedic Aps20141—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K120460SmartluxMedmix Co., Ltd.201218—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+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—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K090762LEDAQuantel Derma GmbH200946—
+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—
+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—
+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—
+4K072459Omnilux New-UPhoto Therapeutics, Inc.200891—