510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K033942Thermage Thermacool SystemThermage, Inc.2004527—
+5K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+5K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.200311
+5K030557Modification to Vnus Closure SystemVnus Medical Technologies, Inc.200321—
+5K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+5K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+5K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc.2002695—
+5K022266Aurora SRSyneron Medical, Ltd.2002705—
+5K021149Aurora DSSyneron Medical, Ltd.2002750—
+5K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+5K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+6K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+6K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+6K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20250—
+6K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+6K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.20241—
+6K232505Endovenous Radiofrequency Generator, Endovenous Radiofrequency CatheterZhejiang Curaway Medical Technology Co., Ltd.20240—
+6K222997VVR Generator systemStarmed Co., Ltd.20230—
+6K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+6K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+6K213627RF Vapor SystemAqua Medical, Inc.20212—
+6K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+6K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.20213—
+6K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+6K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+6K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC20180—
+6K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+6K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+6K162802Barrx Anorectal RFA WandCovidien, LLC20170—
+6K161038PK MorcellatorGyrus Acmi, Inc.20160—
+6K162547Viveve SystemViveve, Inc.20166—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.201632
+6K161661Thermi RF AccessoriesThermi20163—
+6K160360Barrx FLEX RFA Energy GeneratorCovidien, LLC20160—
+6K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc.20160—
+6K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+6K151793InMode RF SystemInmode MD, Ltd.20161—
+6K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+6K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+6K150251Barrx Anorectal RFA WandCovidien, LLC20151—
+6K142350PK J-HookGyrus Acmi, Inc.201511
+6K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+6K141858Closurerfg Radiofrequency GeneratorCovidien20142—
+6K130501IntensifEndymed Medical, Ltd.201457—
+6K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+6K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+6K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+6K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+6K121481Infini Radiofrequency SystemLutronic Corporation201357—
+6K122605PKS BillGyrus Acmi, Inc.20121—
+6K120431HALO90 Ultra Ablation CatheterBarrx Medical, Inc.20120—
+6K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+6K102366Finess EndoscopeEntellus Medical, Inc.20110—
+6K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+6K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+6K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+6K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+6K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+6K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+6K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated200921
+6K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+6K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+6K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+6K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+6K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+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—
+6K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080—
+6K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+6K073464Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure KitAngioDynamics, Inc.20080—
+6K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719—
+6K052936Thermage Thermacool SystemThermage, Inc.2007103—
+6K070536Medilas D Family LasersDornier Medtech America, Inc.2007197—
+6K070004AccentAlma Lasers, Ltd.2007181—
+6K063828Diomed Delta 25Diomed, Ltd.20075—
+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—
+6K060948Portrait PSR3Rhytec Incorporated20061101
+6K061373Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Vnus Medical Technologies, Inc.2006132
+6K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+6K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+6K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+6K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+6K040135Thermage Thermacool SystemThermage, Inc.2004496—
+6K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+6K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20030—
+6K031489PitangaSyneron Medical, Ltd.20030—
+6K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+6K031988Aurora DSSyneron Medical, Ltd.2003450—
+6K031993Aurora SRSyneron Medical, Ltd.2003303—
+6K030426Omnilux RedPhoto Therapeutics Limited2003563—
+6K031046Thermacool TC SystemThermage, Inc.200322—