510(k) Report

Devices descending from K913430

71 later devices reach Iris Oculight (R) SLX through their predicates, nearest generation first.

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