510(k) Report

Devices descending from K031665

21 later devices reach Iris Medical Oculight GL/GLX Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111460Opto Hyalus Green LaserOpto Eletronica S/A20120—
+1K062624Next Generation LaserAlcon Laboratories200718—
+1K062074Iridex Wireless FootswitchIridex Corp20060—
+2K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+2K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+2K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd.201131
+2K101285Constellation Vision SystemAlcon Manufacturing, Ltd.2010174
+3K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc.202402
+3K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+3K212241Quatera 700Carl Zeiss Meditec, AG20221—
+3K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+3K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+3K141065Constellation Vision SystemAlcon Research, Ltd.201426
+3K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+4K250501System SophiThis AG20250—
+4K230858Quatera 700Carl Zeiss Meditec, AG20230—
+4K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC20220—
+4K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+4K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+5K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.20240—
+5K191650LEGION SystemAlcon Research, LLC201901