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
+1K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc.1999350—
+1K980685Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc.1998351—
+1K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.19981,219—
+2K050412VapormaxTrimedyne, Inc.20052—
+2K032838Celon Ent SystemCelon AG Medical Instruments20033—
+2K022338Optical Integrity General Shaped FiberOptical Integrity, Inc.20021—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K020673Wave Form Manufacturing Prolase General Shaped FiberWave Form Mfg., Inc.20022—
+2K014290Entec Plasma WandsArthrocare Corp.2002119—
+2K012631Reprocessed Soft Tissue AblatorsAlliance Medical Corp.20011—
+2K012519Arthrocare Electrosurgery WandsArthrocare Corp.20013—
+2K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+2K992581Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands, Orthowands…Arthrocare Corp.199923—
+2K981870Visage Cosmetic Surgery SystemArthrocare Corp.19981,073—
+3K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…Olympus Winter & Ibe GmbH20250—
+3K191732Sutter RaVoR Bipolar ElectrodesSutter Medizintechnik GmbH20190—
+3K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+3K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+3K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+3K160639Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH20160—
+3K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+3K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+3K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+3K132975Sphinx JRAllmed Systems, Inc.20141—
+3K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+3K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+3K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+3K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+3K091310Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682Dfine, Inc.201011—
+3K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+3K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+3K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+3K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+3K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+3K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+3K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+3K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+3K072261Finesse SystemPrimaeva Medical, Inc.2007100—
+3K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+3K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+3K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060—
+3K053457Vapormax IITrimedyne, Inc.20051—
+3K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+3K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+3K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+3K033547Vnus Vessel and Tissue Coagulation SystemVnus Medical Technologies, Inc.20046—
+3K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+3K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+3K012679Reprocessed RF Arthroscopy ProbesSterilmed, Inc.200101
+3K012129Ortho Development Orion-I Emf SystemOrtho Development Corp.20010—
+3K000944Thermage Thermacool SystemThermage, Inc.20001,069—
+3K992180Visage Cosmetic Surgery, Model V5000Arthrocare Corp.20003—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K211534RevoLix HTLLisa Laser Products GmbH20220—
+4K212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.20220—
+4K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+4K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+4K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+4K180423Empower H65Quanta System Spa20181—
+4K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+4K163449HyPHo Laser SystemHyper Photonics Srl20170—
+4K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+4K163197Cook Holmium Laser FiberCook Incorporated20170—
+4K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+4K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+4K170331Cyber HoQuanta System Spa20179—
+4K163009LithoQuanta System Spa201612—
+4K152744Diego Elite DrillGyrus Acmi, Inc.20160—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+4K142480OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc.20159—
+4K142289PK SpatulaGyrus Acmi, Inc.20141—
+4K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+4K123429Olympus Energy Power System (Eps)Gyrus Acmi, Inc.2013112
+4K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+4K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+4K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+4K121678DTADGyrus Acmi, Inc.20122—
+4K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc.20120—
+4K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc.20113—
+4K110685Flexiva TractipBoston Scientific Corp20112—
+4K110686AccutracBoston Scientific Corp20110—
+4K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+4K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+4K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+4K082391Primaeva Medical Renesis SystemPrimaeva Medical, Inc.200959—
+4K080844G3 Generator and Accessories-Dissector Plasma KnifeGyrus Acmi, Inc.20091—
+4K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+4K083013PK Diego Powered Dissector Console, Model 7033-9050, Diego Trigger-Enabled Powered…Gyrus Acmi, Inc.20080—
+4K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc.20087—
+4K080093PKS Plasma Morcellator, Models 962000PK, 3620PKGyrus Acmi, Inc.20081—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.200844—
+4K080145Primaeva Medical SystemPrimaeva Medical, Inc.200899—
+4K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514—
+4K050460Gyrus Plasmacision and Plasmablend ElectrodesGyrus Medical, Inc.20056—