510(k) Report

Devices descending from K946304

1,420 later devices reach Coherent Family of CO2 Surgical Laser Scanner Handpieces through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K182669Youlaser CO2Quanta System Spa20181—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K180993Beacon Advanced CO2 Laser SystemOmniguide, Inc.20180—
+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—
+4K160312Fraxis DuoIlooda Co,., Ltd.201614—
+4K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+4K152667ATOVEN-Reusable Laser FiberDiotech CO20160—
+4K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153564Pure CryogenAir Liquide Healthcare America Corporation20160—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K150027CYMAWhitecap Technologies, LLC20150—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K150336Photonica ProfessionalWard Photonics, LLC20157—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+4K134017GigalaserPowermedic Aps20141—
+4K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+4K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+4K132975Sphinx JRAllmed Systems, Inc.20141—
+4K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K132754Neogen PSR SystemEnergist, Ltd.20132—
+4K130459Tria Fan SystemTria Beauty, Inc.20131—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123860Inmode SR Ipl DeviceInmode MD, Ltd.20133—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K120460SmartluxMedmix Co., Ltd.201218—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+4K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+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—
+4K102461FractoraInvasix, Ltd.201124—
+4K110434Trixel CO2 LaserBeijing Syntech Laser CO., LTD.201115—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd.201124—
+4K103501Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesAlma Lasers, Inc.201113—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K100415Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis2010101
+4K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+4K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+4K093793LS-40 CO2 Laser System Model LS-40Sandstone Medical Technologies, LLC20103—
+4K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+4K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+4K090762LEDAQuantel Derma GmbH200946—
+4K090837Stratapulse TS and StratapulseAdvanced Medical Photonics20093—
+4K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+4K090399Trios SystemViora, Ltd.20090—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+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—
+4K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K082101LS Family of CO2 Lasers with Scanning HandpieceSandstone Medical Technologies, LLC20080—
+4K081408Ellipse MultiflexEllipse A/S20087—
+4K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+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—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K080932Mosaic Laser SystemLutronic Corporation20086—