510(k) Report

Devices descending from K961747

1,326 later devices reach Arthrocare Arthroscopic Electrosurgery System (Model 970) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+6K132431Thermage CPT SystemSolta Medical, Inc.2013171
+6K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+6K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+6K122966XP200Btl Industries, Ltd.20131—
+6K130283Evrf SystemF Care Systems NV20132—
+6K122605PKS BillGyrus Acmi, Inc.20121—
+6K120460SmartluxMedmix Co., Ltd.201218—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+6K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+6K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+6K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+6K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+6K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+6K101916Joule Multi-Platform SystemSciton, Inc2011111—
+6K102366Finess EndoscopeEntellus Medical, Inc.20110—
+6K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+6K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+6K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+6K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+6K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+6K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+6K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+6K090762LEDAQuantel Derma GmbH200946—
+6K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+6K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+6K082834Ellman International Non-Ablative Technique for Surgitron IecEllman Int'L, Inc.2009561
+6K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009169—
+6K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+6K082247Evis MD Platinum Red Light TherapyAgeless Beauty Corporation20081—
+6K073000LumaprobeClareblend, Inc.20080—
+6K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, Inc.20080—
+6K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+6K073427Medilas D Family LasersDornier Medtech America, Inc.200881—
+6K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+6K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+6K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+6K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+6K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+6K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+6K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+6K072459Omnilux New-UPhoto Therapeutics, Inc.200891—
+6K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+6K073464Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure KitAngioDynamics, Inc.20080—
+6K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd.200784—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K071786Portrait PSRRhytec Incorporated2007109—
+6K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+6K070536Medilas D Family LasersDornier Medtech America, Inc.2007197—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K063828Diomed Delta 25Diomed, Ltd.20075—
+6K060792IllumimedPhotoactif, LLC2006115—
+6K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc.2006132—
+6K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+6K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+6K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc.2006132
+6K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd.2006297—
+6K061117Nanolite Skin Care SystemNanolite Technology, Inc.20060—
+6K052778Thermage Thermacool Skin MarketingThermage, Inc.2005130—
+6K051259Versaclear Skin Therapy System, Model 100Theralight, Inc.200547—
+6K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160—
+6K051255Lumiphase-ROpusmed, Inc.2005143—
+6K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+6K050452Aurora SR and Sra ApplicatorSyneron Medical, Ltd.2005301—
+6K043575Dermillume, Model PRO1000Care Electronics, Inc.20054—
+6K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+6K032514AC Applicator, Aurora ACSyneron Medical, Ltd.20041—
+6K033586Modification to Aurora DSSyneron Medical, Ltd.2003303—
+6K031671Polaris WRSyneron Medical, Ltd.2003678—
+6K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+6K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20030—
+6K030186Polris LVSyneron Medical, Ltd.2003680—
+7K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+7K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC20260—
+7K261202ENTire IRE SystemEntire Medical, Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC20250—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K250688Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency…Acotec Scientific Co., Ltd.20250—
+7K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+7K251327XERFLutronic Corporation202501
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K242241SunnyShenB Co., Ltd.20250—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+7K242688Finiff SystemSkingrab Co., Ltd.20240—
+7K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+7K240248Volnewmer™Classys, Inc.20241—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—