510(k) Report

Devices descending from K133486

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International)201921
+1K170052Stellaris Elite vision enhancement systemBausch+Lomb20171—
+1K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb2017113
+2K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s)…Bausch and Lomb20260—
+2K232084Stellaris Elite vision enhancement systemBausch and Lomb20240—
+2K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+3K250501System SophiThis AG20250—