510(k) Report

Devices descending from K850668

1,030 later devices reach Electrosurgical Unit 774 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K150336Photonica ProfessionalWard Photonics, LLC20157—
+6K134017GigalaserPowermedic Aps20141—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K120460SmartluxMedmix Co., Ltd.201218—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K111887Closurefast Radiofrequency CatheterCovidien20116—
+6K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+6K101916Joule Multi-Platform SystemSciton, Inc2011111—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K090661Nes Reprocessed Varicose Vein RF CatheterNortheast Scientific, Inc.20100—
+6K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103—
+6K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+6K090762LEDAQuantel Derma GmbH200946—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K083737Halo Ablation CatheterBarrx Medical, Incorporated200922—
+6K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917—
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+6K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+6K073000LumaprobeClareblend, Inc.20080—
+6K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+6K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+6K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+6K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+6K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+6K060792IllumimedPhotoactif, LLC2006115—
+6K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+6K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+6K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+6K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+6K051255Lumiphase-ROpusmed, Inc.2005143—
+6K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+6K031671Polaris WRSyneron Medical, Ltd.2003678—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+7K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+7K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+7K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+7K233024Alma HarmonyAlma Lasers, Inc.20241—
+7K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+7K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K213761Joule diVa SystemSciton, Inc20220—
+7K213594Echolaser X4Elesta S.P.A20221—
+7K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+7K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+7K203054FlexSysGme German Medical Engineering GmbH20210—
+7K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+7K192856MT OneM&T S.R.L.20202—
+7K193656SkyPulseFotona D.O.O.202011—
+7K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+7K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+7K191693BC-5Reveallux, Corp20190—
+7K183708Poly ClearMedtek Skincare, LLC201922—
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K173285Joule SystemSciton, Inc20185—
+7K172535Bipolar applicator CELON ProCurve VOlympus Winter & Ibe GmbH20170—
+7K171227StarWalkerFotona D.O.O.20177—
+7K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+7K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+7K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+7K160880Photonica ProfessionalWard Photonics, LLC20166—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+7K153229SuperbiumBios S.R.L.20162—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—