510(k) Report

Devices descending from K011703

342 later devices reach Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+1K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+1K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+1K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+1K132975Sphinx JRAllmed Systems, Inc.20141—
+1K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+1K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+1K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+1K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+1K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+1K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+1K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+1K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+1K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+1K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+1K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+1K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+1K050412VapormaxTrimedyne, Inc.20052—
+1K014290Entec Plasma WandsArthrocare Corp.2002119—
+2K211534RevoLix HTLLisa Laser Products GmbH20220—
+2K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+2K180423Empower H65Quanta System Spa20181—
+2K163449HyPHo Laser SystemHyper Photonics Srl20170—
+2K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+2K163197Cook Holmium Laser FiberCook Incorporated20170—
+2K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+2K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+2K170331Cyber HoQuanta System Spa20179—
+2K163009LithoQuanta System Spa201612—
+2K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+2K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+2K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+2K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+2K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+2K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+2K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+2K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+2K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+2K110685Flexiva TractipBoston Scientific Corp20112—
+2K110686AccutracBoston Scientific Corp20110—
+2K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+2K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+2K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+2K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+2K053457Vapormax IITrimedyne, Inc.20051—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+2K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+3K260100MOSES Raydar™Boston Scientific Corporation20260—
+3K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+3K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+3K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+3K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+3K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+3K232106Air Gap FiberWontech Co., Ltd.20240—
+3K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+3K213252Dornier ThulioDornier Medtech America, Inc.20220—
+3K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+3K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+3K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+3K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+3K200234Surgical laser fibersQuanta System Spa20202—
+3K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+3K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+3K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+3K180426Empower H35Quanta System Spa20181—
+3K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+3K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+3K172025Litho 60Quanta System Spa20178—
+3K161771Medilas H Laser FibersDornier Medtech America, Inc.20160—
+3K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+3K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+3K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+3K131805Inpulse LaserIncisive, Inc.20130—
+3K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+3K130413Pinpointe FootlaserNuvolase, Inc.20130—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K120938The PL-1064 Laser SystemSheaumann Laser, Inc.201214—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K110375Blueshine's Gold SeriesBlueshine Srl20124—
+3K111483Joule Clearsense Laser SystemSciton, Inc20110—
+3K103338CooltouchNew Star Lasers, Inc.201101
+3K110370Q-ClearLight Age, Inc.201135—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+3K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+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—
+3K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—
+3K030108Arthrocare Ent Coblator Surgery SystemArthrocare Corp.2003921
+4K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation20260—
+4K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+4K251996ENTire IRE SystemEntire Medical, Ltd.20261—
+4K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+4K251824Patriot DuoPatriot Laser, LLC20250—
+4K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+4K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+4K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—