510(k) Report

Devices descending from K063331

24 later devices reach Bausch & Lomb NGX Microsurgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133242Stellaris Vision Enhancement SystemBausch & Lomb20144—
+1K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc.2010141
+1K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV20098—
+1K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc.2009224
+2K170052Stellaris Elite vision enhancement systemBausch+Lomb20171—
+2K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb2017113
+2K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+2K133562Catarhex 3Oertli Instrumente AG20141—
+2K133486Stellaris PC Vision Enhancement SystemBausch & Lomb201473
+2K121555Centurion Vision SystemAlcon Laboratories, Inc.201264
+3K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s)…Bausch and Lomb20260—
+3K233398Faros Surgical SystemOertli Instrumente AG20240—
+3K232084Stellaris Elite vision enhancement systemBausch and Lomb20240—
+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
+3K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd.20173—
+3K141065Constellation Vision SystemAlcon Research, Ltd.201426
+4K250501System SophiThis AG20250—
+4K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+4K233902Centurion™ Vision System (Active Sentry™) (8065753057)Alcon Laboratories, Inc.20240—
+4K230858Quatera 700Carl Zeiss Meditec, AG20230—
+4K193376Visalis V500, Visalis S500Carl Zeiss Meditec, AG20200—
+4K191650LEGION SystemAlcon Research, LLC201901