510(k) Report

Devices descending from K031774

5 later devices reach Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043540Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc.20054—
+2K080686Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co.20080—
+2K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts20072—
+3K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+4K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—