510(k) Report

Devices descending from K895518

352 later devices reach Coherent Holmium:Yag Surgical Laser 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—
+2K050412VapormaxTrimedyne, Inc.20052—
+2K022338Optical Integrity General Shaped FiberOptical Integrity, Inc.20021—
+2K020673Wave Form Manufacturing Prolase General Shaped FiberWave Form Mfg., Inc.20022—
+2K012519Arthrocare Electrosurgery WandsArthrocare Corp.20013—
+2K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+3K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+3K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+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
+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—
+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—
+3K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+3K053457Vapormax IITrimedyne, Inc.20051—
+3K014290Entec Plasma WandsArthrocare Corp.2002119—
+3K014222Arthrocare Controller, Patient Cable, Foot Control, Power CordArthrocare Corp.20022—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K211534RevoLix HTLLisa Laser Products GmbH20220—
+4K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+4K180423Empower H65Quanta System Spa20181—
+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—
+4K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+4K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+4K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+4K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+4K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+4K110685Flexiva TractipBoston Scientific Corp20112—
+4K110686AccutracBoston Scientific Corp20110—
+4K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+4K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+4K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+4K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+4K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+4K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+4K020622Arthrocare Controller (System 2000 and 8000); Arthrocare Cable; Foot Control; Power…Arthrocare Corp.20021—
+5K260100MOSES Raydar™Boston Scientific Corporation20260—
+5K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+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—
+5K213252Dornier ThulioDornier Medtech America, Inc.20220—
+5K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+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—
+5K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+5K200234Surgical laser fibersQuanta System Spa20202—
+5K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+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—
+5K180426Empower H35Quanta System Spa20181—
+5K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+5K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+5K172025Litho 60Quanta System Spa20178—
+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—
+5K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+5K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated…ArthroCare Corporation201443
+5K131805Inpulse LaserIncisive, Inc.20130—
+5K122652Arthrocare Turbinator WandArthroCare Corporation20133—
+5K130413Pinpointe FootlaserNuvolase, Inc.20130—
+5K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.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—
+5K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+5K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018—
+5K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098—
+5K041633Gyrus Plasmacision Laparoscopic SpatulaGyrus Medical, Inc.20048—
+5K041285Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision…Gyrus Medical, Ltd.2004202
+5K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC200450—
+5K030033Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd.20030—