510(k) Report

Devices descending from K914136

1,315 later devices reach Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K052003Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX =…Vnus Medical Technologies, Inc.20055—
+4K043402Thermage Thermacool SystemThermage, Inc.2005124—
+4K033942Thermage Thermacool SystemThermage, Inc.2004527—
+4K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+4K023111Gyrus Plasma Skin Resurfacing SystemGyrus Medical, Inc.20030—
+4K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+4K021402Thermage Thermacool TC SystemThermage, Inc.2002789—
+4K022266Aurora SRSyneron Medical, Ltd.2002705—
+4K021149Aurora DSSyneron Medical, Ltd.2002750—
+4K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp.20021—
+4K013639Thermage Thermacool TC SystemThermage, Inc.2002799—
+4K013034Modification to: Thermacool IiaThermage, Inc.2001800—
+5K260100MOSES Raydar™Boston Scientific Corporation20260—
+5K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+5K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+5K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+5K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+5K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+5K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+5K232106Air Gap FiberWontech Co., Ltd.20240—
+5K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+5K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System…ArthroCare Corporation20230—
+5K213252Dornier ThulioDornier Medtech America, Inc.20220—
+5K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+5K213831Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGyrus Acmi, Inc.20220—
+5K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc.202121
+5K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+5K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+5K200234Surgical laser fibersQuanta System Spa20202—
+5K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+5K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)20180—
+5K180426Empower H35Quanta System Spa20181—
+5K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+5K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C20181—
+5K172025Litho 60Quanta System Spa20178—
+5K171094Thermi Reusable Non-invasive RF ElectrodeThermgen, L.L.C20176—
+5K161038PK MorcellatorGyrus Acmi, Inc.20160—
+5K162547Viveve SystemViveve, Inc.20166—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K161661Thermi RF AccessoriesThermi20163—
+5K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+5K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+5K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+5K151793InMode RF SystemInmode MD, Ltd.20161—
+5K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+5K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+5K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+5K142350PK J-HookGyrus Acmi, Inc.201511
+5K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+5K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+5K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+5K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+5K131805Inpulse LaserIncisive, Inc.20130—
+5K121481Infini Radiofrequency SystemLutronic Corporation201357—
+5K130413Pinpointe FootlaserNuvolase, Inc.20130—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+5K122605PKS BillGyrus Acmi, Inc.20121—
+5K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+5K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+5K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K110375Blueshine's Gold SeriesBlueshine Srl20124—
+5K111483Joule Clearsense Laser SystemSciton, Inc20110—
+5K103338CooltouchNew Star Lasers, Inc.201101
+5K110370Q-ClearLight Age, Inc.201135—
+5K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K102366Finess EndoscopeEntellus Medical, Inc.20110—
+5K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+5K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+5K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+5K091674Arthrocare Coblator IQ SystemArthrocare Corp.20101—
+5K092191Exilis, Model 5000Btl Industries, Ltd.200912—
+5K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+5K083352Veinwave, TC3000Newlands Clinical Trials, Ltd.20094—
+5K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O.200913—
+5K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics20081—
+5K081766PKS Omni InstrumentGyrus-Acmi L.P.200831
+5K081954Gyrus Acmi General Surgery Workstation, Model G400, and Dual Footswitch Connector CableGyrus Acmi, Inc.20080—
+5K071759LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand…Live Tissue Connect, Inc.20080—
+5K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.200842—
+5K072849Modification to Thermage Thermacool SystemThermage, Inc.200820—
+5K052936Thermage Thermacool SystemThermage, Inc.2007103—
+5K070004AccentAlma Lasers, Ltd.2007181—
+5K060948Portrait PSR3Rhytec Incorporated20061101
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+5K051710Thermage Thermacool Coupling FluidThermage, Inc.200556—
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+5K040135Thermage Thermacool SystemThermage, Inc.2004496—
+5K033257Arthrocare Ent Plasma WandsArthrocare Corp.200342—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K032088Modification to Thermacool TC SystemThermage, Inc.2003131—
+5K031988Aurora DSSyneron Medical, Ltd.2003450—
+5K031993Aurora SRSyneron Medical, Ltd.2003303—
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—