510(k) Report

Devices descending from K961943

11 later devices reach Flexlens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080512Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue…Metro Optics of Austin, Inc.20089—
+1K030593Flexlens and Harrison Post Refractive Surgery (Bioxifilcon a), (Hioxifilcon B)…X-Cel Contacts, A Walman Co.20030—
+2K100244Metro SoftMetro Optics of Austin, Inc.20108—
+3K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Metro Optics of Austin, Inc.20240—
+3K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+3K121652Cvue Advanced Hydra VueUnilens Corp., USA20120—
+4K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+5K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+6K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+7K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+8K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—