510(k) Report

Devices descending from K963123

1,324 later devices reach Arthrocare Arthroscopic Eletrosurgery System (Model 980) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+4K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+4K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+4K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated20080—
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+4K052936Thermage Thermacool SystemThermage, Inc.2007103—
+4K070353Kelsey Intersitital Laser Therapy SystemKelsey, Inc.20071—
+4K070004AccentAlma Lasers, Ltd.2007181—
+4K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063—
+4K060948Portrait PSR3Rhytec Incorporated20061101
+4K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620—
+4K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629—
+4K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+4K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—
+4K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+4K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.200589—
+4K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+4K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+4K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+4K042132Novasys Transurethral RF SystemNovasys Medical, Inc.200401
+4K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc.20042971
+4K040921Cooltouch, Model NS 160Cooltouch, Inc.2004204—
+4K040135Thermage Thermacool SystemThermage, Inc.2004496—
+4K040638Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc.200410—
+4K031489PitangaSyneron Medical, Ltd.20030—
+4K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+4K031988Aurora DSSyneron Medical, Ltd.2003450—
+4K031993Aurora SRSyneron Medical, Ltd.2003303—
+4K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+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—
+4K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+4K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc.2002695—
+5K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+5K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+5K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+5K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc.202511
+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—
+5K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+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—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K210077MED RF 4000F Care Systems USA, LLC20211—
+5K213627RF Vapor SystemAqua Medical, Inc.20212—
+5K211217Profound MatrixCandela Corporation20210—
+5K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+5K192621Medical RFTriworks Group Srl20200—
+5K193201BTL-785FBtl20208—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation20181—
+5K180872Scarlet SRFVIOL Co., Ltd.20184—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K180584Viveve RF System, SecureViveve, Inc.20185—
+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—
+5K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+5K162851eLyx-PROIntelligent Sensory Concept SA20170—
+5K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+5K163190InMode RF SystemInmode MD, Ltd.20160—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.201632
+5K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc.201627—
+5K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+5K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.20160—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+5K150409VIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd201681
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+5K150336Photonica ProfessionalWard Photonics, LLC20157—
+5K142350PK J-HookGyrus Acmi, Inc.201511
+5K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+5K141858Closurerfg Radiofrequency GeneratorCovidien20142—
+5K133405MinnieElettronica Valseriana Srl20140—
+5K134017GigalaserPowermedic Aps20141—
+5K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+5K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+5K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+5K132431Thermage CPT SystemSolta Medical, Inc.2013171