510(k) Report

Devices descending from K850668

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971532Arthrocare Electrosurgery SystemArthrocare Corp.19971,029—
+2K062539Ncontact Coagulation System KitNcontact Surgical, Inc.20060—
+2K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242—
+2K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc.20023—
+2K013139Stellartech Coagulation SystemStellartech Research Corp.200142—
+2K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+2K992972Arthrocare System 2000 Controller, Arthrocare Cable, Footswitch, Powercord, Arthrocare…Arthrocare Corp.19993—
+2K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998977—
+3K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014—
+3K072126Habib VesealEmcision, Ltd.20070—
+3K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060—
+3K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+3K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.200534—
+3K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.200435—
+3K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.200436—
+3K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200437—
+3K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200338—
+3K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.200339—
+3K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.200341—
+3K023624SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc.20032—
+3K020952Surx RF SystemSurx, Inc.20021—
+3K014251Ntero Hotrod SystemNtero Surgical, Inc.20020—
+3K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc.20022—
+3K012398Diomed 15 Diode LaserDiomed, Ltd.2002714—
+3K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999973—
+4K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.20194—
+4K141357Barrx Flex Rfa Energy GeneratorCovidien Iic20141—
+4K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC20131—
+4K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124—
+4K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.201011
+4K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+4K070353Kelsey Intersitital Laser Therapy SystemKelsey, Inc.20071—
+4K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+4K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+4K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+4K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+4K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.200589—
+4K042132Novasys Transurethral RF SystemNovasys Medical, Inc.200401
+4K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc.20042971
+4K040921Cooltouch, Model NS 160Cooltouch, Inc.2004204—
+4K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc.200410—
+4K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+4K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.200311
+4K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc.200321—
+4K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc.2002695—
+4K022266Aurora SRSyneron Medical, Ltd.2002705—
+5K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+5K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+5K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+5K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterZhejiang Curaway Medical Technology Co., Ltd.20240—
+5K222997VVR Generator systemStarmed Co., Ltd.20230—
+5K213627RF Vapor SystemAqua Medical, Inc.20212—
+5K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+5K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+5K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+5K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+5K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+5K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+5K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.201632
+5K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+5K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+5K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.20160—
+5K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+5K141858Closurerfg Radiofrequency GeneratorCovidien20142—
+5K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+5K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+5K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+5K073427Medilas D Family LasersDornier Medtech America, Inc.200881—
+5K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+5K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K073464Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure KitAngioDynamics, Inc.20080—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+5K070536Medilas D Family LasersDornier Medtech America, Inc.2007197—
+5K063828Diomed Delta 25Diomed, Ltd.20075—
+5K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc.2006132—
+5K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated200626—
+5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+5K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc.2006132
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+5K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20030—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K031993Aurora SRSyneron Medical, Ltd.2003303—
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—
+5K030186Polris LVSyneron Medical, Ltd.2003680—
+6K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)F Care Systems USA, LLC20260—
+6K250688Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency…Acotec Scientific Co., Ltd.20250—
+6K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc.20250—
+6K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterMedtronic, Inc.20230—
+6K202288FinebeamSNJ Co., Ltd.20212—
+6K200104OxylightRaja Trading Company, Inc.202024—
+6K191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC20190—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K162851eLyx-PROIntelligent Sensory Concept SA20170—