510(k) Report

Devices descending from K885196

297 later devices reach Laser Indirect Ophthalmoscope (Lio) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022181Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc.200265—
+1K991258Novus Verdi Delivery SystemsLumenis, Inc.1999296—
+2K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus…Lumenis, Ltd.20170—
+2K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+2K111213Vision One Laser SystemLumenis, Inc.201111
+2K091981Lightlas 577 Medical Optical Pumped Semiconductor LaserLightmed Corp.20090—
+2K081704Selecta Family of Ophithalmic Laser SystemsLumenis, Inc.20089—
+2K072514Visulas TrionCarl Zeiss Meditec, AG20071—
+2K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation20061—
+2K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc.20061—
+2K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc.20054—
+2K051944Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo)…Lumenis, Inc.20051—
+2K052129Lumenis 1000 Integrated Slit LampLumenis, Inc.20055—
+2K050738FT Fiber Optic Delivery SystemsFibertech GmbH20052255
+2K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc.200529—
+2K043236Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical20056—
+2K042785Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc.200415—
+2K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc.20035—
+2K023464Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical20037—
+3K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc.20222—
+3K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+3K140366Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC20141—
+3K140336Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical20143—
+3K130195Scanning LaserlinkLumenis, Inc.201301
+3K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+3K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+3K130933SolutisQuantel Medical20134—
+3K122251Vitra MultispotQuantel Medical20131—
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)20120—
+3K110228Nidek Multicolor Laser PhotocoagulatorNidek Incorporated201194
+3K103056Visulas Trion Laser System with the Vite OptionCarl Zeiss Meditec, AG20110—
+3K100035Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG20104—
+3K091064Navilas Laser SystemOd-Os GmbH20093—
+3K090774Lightlas SelectorLightmed Corp.20090—
+3K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation200923—
+3K081946Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical20092—
+3K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+3K081744Pascal Synthesis Delivery SystemOptimedica Corporation200817—
+3K070776Supra Ophthalmic Laser PhotocoagulatorQuantel Medical20073—
+3K060338Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta Duet…Lumenis, Inc.20060—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K230722Eagle deviceBelkin Vision, Ltd.20231—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K220430CapsuloQuantel Medical20220—
+4K201502Vitra 810Quantel Medical20200—
+4K191962Vitra 2Quantel Medical20190—
+4K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.20191—
+4K181682VISULAS greenCarl Zeiss Meditec, AG20192—
+4K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+4K163197Cook Holmium Laser FiberCook Incorporated20170—
+4K152667ATOVEN-Reusable Laser FiberDiotech CO20160—
+4K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd.20166—
+4K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K141851Navilas Laser SystemOd-Os GmbH20152—
+4K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+4K133358Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the…Nidek Co., Ltd.201402
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K111643Opto Mitra Yellow LaserOpto Electronica SA20110—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K100678Supra Scan Delivery SystemQuantel Medical201011—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc.200922—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K252979Voyager DSLT (430840610)Belkin Vision, Ltd.20260—
+5K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+5K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+5K232106Air Gap FiberWontech Co., Ltd.20240—
+5K232051VISULAS greenCarl Zeiss Meditec20231—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+5K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+5K203130Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.20200—
+5K193656SkyPulseFotona D.O.O.202011—
+5K200234Surgical laser fibersQuanta System Spa20202—
+5K190083Leaf PhotocoagulatorNorlase Aps20193—
+5K173285Joule SystemSciton, Inc20185—
+5K170302Yellow Laser Photocoagulator Ylc-500Nidek Co., Ltd.20171—
+5K162191NAVILAS Laser SystemOd-Os GmbH20161—
+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—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+5K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+5K120825Supra Scan Delivery SystemQuantel Medical20121—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K100019Pascal Streamline PhotocoagulatorOptimedica Corporation2010161
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—