510(k) Report

Devices descending from K800617

1,325 later devices reach Hyfrecator, #733 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+4K031988Aurora DSSyneron Medical, Ltd.2003450—
+4K031993Aurora SRSyneron Medical, Ltd.2003303—
+4K030426Omnilux RedPhoto Therapeutics Limited2003563—
+4K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.200311
+4K031046Thermacool TC SystemThermage, Inc.200322—
+4K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc.200321—
+4K024064Polaris DSSyneron Medical, Ltd.2003681—
+4K030142Thermacool TC SystemThermage, Inc.2003773—
+4K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc.2002695—
+4K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+4K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+4K012129Ortho Development Orion-I Emf SystemOrtho Development Corp.20010—
+5K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+5K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+5K240070Profound MatrixCandela Corporation20240—
+5K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterZhejiang Curaway Medical Technology Co., Ltd.20240—
+5K222997VVR Generator systemStarmed Co., Ltd.20230—
+5K231749Radio Frequency SystemShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+5K222556BTL-785XBTL Industries, Inc.20235—
+5K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+5K222709Retraction, CWM-910T, APOLEX TiteChungwoo Co., Ltd.20230—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+5K210077MED RF 4000F Care Systems USA, LLC20211—
+5K213627RF Vapor SystemAqua Medical, Inc.20212—
+5K211217Profound MatrixCandela Corporation20210—
+5K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+5K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+5K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+5K192621Medical RFTriworks Group Srl20200—
+5K193201BTL-785FBtl20208—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+5K180872Scarlet SRFVIOL Co., Ltd.20184—
+5K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180584Viveve RF System, SecureViveve, Inc.20185—
+5K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+5K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+5K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K172023CelfirmVIOL Co., Ltd.20173—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K170116Thermi Injectable RF ElectrodesThermi20172—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+5K163190InMode RF SystemInmode MD, Ltd.20160—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.201632
+5K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+5K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+5K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+5K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.20160—
+5K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+5K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+5K150336Photonica ProfessionalWard Photonics, LLC20157—
+5K142289PK SpatulaGyrus Acmi, Inc.20141—
+5K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+5K141858Closurerfg Radiofrequency GeneratorCovidien20142—
+5K133405MinnieElettronica Valseriana Srl20140—
+5K134017GigalaserPowermedic Aps20141—
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K132431Thermage CPT SystemSolta Medical, Inc.2013171
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K122966XP200Btl Industries, Ltd.20131—
+5K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+5K130283Evrf SystemF Care Systems NV20132—
+5K120460SmartluxMedmix Co., Ltd.201218—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K121678DTADGyrus Acmi, Inc.20122—
+5K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K112334Vein-Gogh InstrumentRefine USA, LLC20120—
+5K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+5K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+5K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+5K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc.201053—
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+5K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+5K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104—
+5K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+5K090762LEDAQuantel Derma GmbH200946—
+5K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+5K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+5K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—