510(k) Report

Devices descending from K091327

2 later devices reach Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230954Samfilcon B Custom Contact LensBausch + Lomb, Incorporated20230—
+1K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc.20140—