510(k) Report

Devices descending from K153168

1 later device reach Bi-Blade Vitrectomy Cutter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565…Bausch and Lomb, Incorporated20260—