510(k) Report

Devices descending from K040303

5 later devices reach 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensVisco Vision, Inc.20200—
+1K201268Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Plexus Optix, Inc.20203—
+2K222885Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation20232—
+3K232649Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation20241—
+4K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation20250—