510(k) Report

Devices descending from K122220

1 later device reach Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc.20140—