510(k) Report

Devices descending from K982031

22 later devices reach Oculight GL with the Dermatology Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp200321—
+2K111460Opto Hyalus Green LaserOpto Eletronica S/A20120—
+2K062624Next Generation LaserAlcon Laboratories200718—
+2K062074Iridex Wireless FootswitchIridex Corp20060—
+3K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+3K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+3K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd.201131
+3K101285Constellation Vision SystemAlcon Manufacturing, Ltd.2010174
+4K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc.202402
+4K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+4K212241Quatera 700Carl Zeiss Meditec, AG20221—
+4K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+4K170520HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…Alcon Research, Ltd.20171—
+4K141065Constellation Vision SystemAlcon Research, Ltd.201426
+4K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+5K250501System SophiThis AG20250—
+5K230858Quatera 700Carl Zeiss Meditec, AG20230—
+5K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC20220—
+5K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+5K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+6K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.20240—
+6K191650LEGION SystemAlcon Research, LLC201901