510(k) Report

Devices descending from K080512

9 later devices reach Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100244Metro SoftMetro Optics of Austin, Inc.20108—
+2K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Metro Optics of Austin, Inc.20240—
+2K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+2K121652Cvue Advanced Hydra VueUnilens Corp., USA20120—
+3K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+4K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+5K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+6K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+7K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—