510(k) Report

Devices descending from K070308

2 later devices reach Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+2K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—