510(k) Report

Devices descending from K951910

480 later devices reach Odyssey HO:Yag Surgical Laser Systems & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+1K060114Vectra Laser SystemXintec Corporation, Dba,2006233—
+1K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis20013422
+2K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+2K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+2K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+2K140120EPIC 10Biolase, Inc.20141—
+2K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+2K132975Sphinx JRAllmed Systems, Inc.20141—
+2K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+2K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+2K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+2K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+2K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+2K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+2K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+2K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+2K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+2K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+2K082938EzlaseBiolase Technology, Inc.200850—
+2K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+2K073411LiteduoLight Instruments20081—
+2K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070—
+2K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+2K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+2K050412VapormaxTrimedyne, Inc.20052—
+2K014290Entec Plasma WandsArthrocare Corp.2002119—
+3K211534RevoLix HTLLisa Laser Products GmbH20220—
+3K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+3K180423Empower H65Quanta System Spa20181—
+3K163449HyPHo Laser SystemHyper Photonics Srl20170—
+3K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+3K163197Cook Holmium Laser FiberCook Incorporated20170—
+3K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+3K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+3K170331Cyber HoQuanta System Spa20179—
+3K163009LithoQuanta System Spa201612—
+3K161185LUCERNA Dental LaserViax Dental Lab20160—
+3K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy20160—
+3K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+3K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+3K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+3K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+3K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+3K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+3K123353Ciq Controller, Ciq WandsArthroCare Corporation20130—
+3K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+3K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+3K123385Medilas H Laser FibersDornier Medtech America, Inc.20120—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K110685Flexiva TractipBoston Scientific Corp20112—
+3K110686AccutracBoston Scientific Corp20110—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+3K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+3K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+3K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+3K070374Arthrocare Ent Plasma WandArthrocare Corp.2007391
+3K053457Vapormax IITrimedyne, Inc.20051—
+3K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC200276—
+3K021364Modification to Entec Plasma WandsArthrocare Corp.200294—
+4K260100MOSES Raydar™Boston Scientific Corporation20260—
+4K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+4K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+4K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+4K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser…Boston Scientific Corporation20250—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K232106Air Gap FiberWontech Co., Ltd.20240—
+4K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K213252Dornier ThulioDornier Medtech America, Inc.20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+4K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+4K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter…ArthroCare Corporation20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K200234Surgical laser fibersQuanta System Spa20202—
+4K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation20193—
+4K192430Epic 980Biolase, Inc.20195—
+4K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+4K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+4K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+4K180426Empower H35Quanta System Spa20181—
+4K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—
+4K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.20180—
+4K173285Joule SystemSciton, Inc20185—
+4K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+4K172025Litho 60Quanta System Spa20178—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—