510(k) Report

Devices descending from K101325

14 later devices reach Stellaris PC Vision Enhancement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+1K133562Catarhex 3Oertli Instrumente AG20141—
+1K133486Stellaris PC Vision Enhancement SystemBausch & Lomb201473
+1K133242Stellaris Vision Enhancement SystemBausch & Lomb20144—
+2K233398Faros Surgical SystemOertli Instrumente AG20240—
+2K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+2K212241Quatera 700Carl Zeiss Meditec, AG20221—
+2K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+2K170052Stellaris Elite vision enhancement systemBausch+Lomb20171—
+2K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb2017113
+3K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s)…Bausch and Lomb20260—
+3K250501System SophiThis AG20250—
+3K232084Stellaris Elite vision enhancement systemBausch and Lomb20240—
+3K230858Quatera 700Carl Zeiss Meditec, AG20230—