510(k) Report

Devices descending from K903639

71 later devices reach Nidek DC-3000 Diode Laser Photocoagulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc.20035—
+1K013760DC-3300 Laser Diode PhotocoagulatorNidek, Inc.200270—
+2K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc.20054—
+2K023464Viridis Twin Ophthalmic PhotocoagulatorQuantel Medical20037—
+2K023094Iridis Ophthalmic PhotocoagulatorQuantel Medical20020—
+2K020374Oculight SL/SLXIridex Corp200269—
+3K202760Iridex 810 LaserIridex Corporation20201—
+3K081946Supra Twin Ophthalmic Laser PhotocoagulatorQuantel Medical20092—
+3K062074Iridex Wireless FootswitchIridex Corp20060—
+3K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation20061—
+3K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc.20061—
+3K043486Pascal Photocoagulator, Product-Pascal-01Topcon Medical Laser Systems, Inc.200529—
+3K043236Frequency Doubled ND: Yag Photocoagulator, Model VitraQuantel Medical20056—
+3K040209Iris Medical IQ 810 PhotocoagulatorIridex Corp20040—
+3K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp200321—
+3K022228Family of Iris Medical Endoprobe HandpiecesIridex Corp20021—
+4K213592Iridex 810 LaserIridex Corporation20220—
+4K201502Vitra 810Quantel Medical20200—
+4K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+4K133019Fiberion Ophthalmic Endolaser ProbeEmtron Elektronik VE Mekanik Sanayi VE Ticaret Lim20150—
+4K122251Vitra MultispotQuantel Medical20131—
+4K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)20120—
+4K111460Opto Hyalus Green LaserOpto Eletronica S/A20120—
+4K103056Visulas Trion Laser System with the Vite OptionCarl Zeiss Meditec, AG20110—
+4K100035Model Visulas 532S Laser with the Vite OptionCarl Zeiss Meditec, AG20104—
+4K091064Navilas Laser SystemOd-Os GmbH20093—
+4K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation200923—
+4K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+4K081744Pascal Synthesis Delivery SystemOptimedica Corporation200817—
+4K062624Next Generation LaserAlcon Laboratories200718—
+4K070776Supra Ophthalmic Laser PhotocoagulatorQuantel Medical20073—
+5K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+5K191962Vitra 2Quantel Medical20190—
+5K181682VISULAS greenCarl Zeiss Meditec, AG20192—
+5K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+5K141851Navilas Laser SystemOd-Os GmbH20152—
+5K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd.201131
+5K101285Constellation Vision SystemAlcon Manufacturing, Ltd.2010174
+5K100678Supra Scan Delivery SystemQuantel Medical201011—
+5K092621Pascal Streamline PhotocoagulatorTopcon Medical Laser Systems, Inc.200922—
+6K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc.202402
+6K232051VISULAS greenCarl Zeiss Meditec20231—
+6K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+6K212241Quatera 700Carl Zeiss Meditec, AG20221—
+6K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+6K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+6K162191NAVILAS Laser SystemOd-Os GmbH20161—
+6K141065Constellation Vision SystemAlcon Research, Ltd.201426
+6K123542Pascal Synthesis (532NM/577NM) Opthalmic LaserTopcon Medical Laser Systems, Inc.201351
+6K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+6K121475Txcell Scanning Laser Delivery SystemIridex Corp20126—
+6K120825Supra Scan Delivery SystemQuantel Medical20121—
+6K100019Pascal Streamline PhotocoagulatorOptimedica Corporation2010161
+7K250501System SophiThis AG20250—
+7K251772Navilas Laser System 577sl (156691)Od-Os GmbH20250—
+7K233911VISULAS combiCarl Zeiss Meditec, AG20240—
+7K230858Quatera 700Carl Zeiss Meditec, AG20230—
+7K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex Corporation20221—
+7K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC20220—
+7K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+7K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc.20171—
+7K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls)20170—
+7K170067EasyretQuantel Medical20170—
+7K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+7K130195Scanning LaserlinkLumenis, Inc.201301
+7K111108Pascal Streamline 577 (with Accessories)Topcon Medical Laser Systems, Inc.201115—
+8K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.20240—
+8K191650LEGION SystemAlcon Research, LLC201901
+8K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStarTopcon Medical Laser Systems, Inc.20180—
+8K142172Lightmed Truscan 577Lightmed Corp.20151—
+9K190448LightLas Pattern Scanning System - TruScan ProLight-Med (Usa), Inc.20190—