510(k) Report

Devices descending from K932468

67 later devices reach Novus Multiwavelength through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022181Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc.200265—
+1K974732Nidek Multi Color Laser Photocoagulator, Model MC-7000Nidek, Inc.19980—
+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—
+2K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc.200529—
+2K042785Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc.200415—
+2K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc.20035—
+3K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc.20222—
+3K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+3K140336Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical20143—
+3K130195Scanning LaserlinkLumenis, Inc.201301
+3K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+3K130933SolutisQuantel Medical20134—
+3K122251Vitra MultispotQuantel Medical20131—
+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—
+3K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+3K081744Pascal Synthesis Delivery SystemOptimedica Corporation200817—
+3K060338Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta Duet…Lumenis, Inc.20060—
+4K230722Eagle deviceBelkin Vision, Ltd.20231—
+4K220430CapsuloQuantel Medical20220—
+4K191962Vitra 2Quantel Medical20190—
+4K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.20191—
+4K181682VISULAS greenCarl Zeiss Meditec, AG20192—
+4K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd.20166—
+4K141851Navilas Laser SystemOd-Os GmbH20152—
+4K133358Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the…Nidek Co., Ltd.201402
+4K111643Opto Mitra Yellow LaserOpto Electronica SA20110—
+4K100678Supra Scan Delivery SystemQuantel Medical201011—
+4K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc.200922—
+5K252979Voyager DSLT (430840610)Belkin Vision, Ltd.20260—
+5K232051VISULAS greenCarl Zeiss Meditec20231—
+5K203130Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.20200—
+5K190083Leaf PhotocoagulatorNorlase Aps20193—
+5K170302Yellow Laser Photocoagulator Ylc-500Nidek Co., Ltd.20171—
+5K162191NAVILAS Laser SystemOd-Os GmbH20161—
+5K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+5K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+5K120825Supra Scan Delivery SystemQuantel Medical20121—
+5K100019Pascal Streamline PhotocoagulatorOptimedica Corporation2010161
+6K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+6K233911VISULAS combiCarl Zeiss Meditec, AG20240—
+6K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+6K222157ECHO PhotocoagulatorNorlase20220—
+6K201623LION PhotocoagulatorNorlase Aps20201—
+6K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc.20171—
+6K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls)20170—
+6K170067EasyretQuantel Medical20170—
+6K111108Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc.201115—
+7K251507Integre LioQuantel Medical20260—
+7K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStarTopcon Medical Laser Systems, Inc.20180—
+7K142172Lightmed Truscan 577Lightmed Corp.20151—
+8K190448LightLas Pattern Scanning System - TruScan ProLight-Med (Usa), Inc.20190—