510(k) Report

Devices descending from K960413

483 later devices reach Coherent Slimline Single Lumen Aspiration Needle Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050738FT Fiber Optic Delivery SystemsFibertech GmbH20052255
+1K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc.1999350—
+1K980838Reusable Megabeam Fiber Optic Delivery SystemCeram Optec, Inc.19981—
+1K980685Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc.1998351—
+2K140366Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC20141—
+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—
+2K113688Megabeam Reusable Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20120—
+2K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+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
+3K213761Joule diVa SystemSciton, Inc20220—
+3K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+3K163197Cook Holmium Laser FiberCook Incorporated20170—
+3K153124DuraLazeTM HoLEP Laser FiberMedkey, LLC20160—
+3K152667ATOVEN-Reusable Laser FiberDiotech CO20160—
+3K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+3K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+3K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+3K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+3K132975Sphinx JRAllmed Systems, Inc.20141—
+3K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+3K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K100194Optical Integrity Laserguard FibersOptical Integrity, Inc.20100—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+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—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+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—
+4K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K232106Air Gap FiberWontech Co., Ltd.20240—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K211534RevoLix HTLLisa Laser Products GmbH20220—
+4K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+4K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser…Boston Scientific202117
+4K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+4K193656SkyPulseFotona D.O.O.202011—
+4K200234Surgical laser fibersQuanta System Spa20202—
+4K180423Empower H65Quanta System Spa20181—
+4K173285Joule SystemSciton, Inc20185—
+4K163449HyPHo Laser SystemHyper Photonics Srl20170—
+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—
+4K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+4K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+4K152591Medilas H RFID Laser FibersDornier Medtech America, Inc.20151—
+4K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy20150—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+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—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110685Flexiva TractipBoston Scientific Corp20112—
+4K110686AccutracBoston Scientific Corp20110—
+4K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC)2010122—
+4K093547Pinpointe FootlaserPinpointe USA, Inc.2010115—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss201001
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+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—