510(k) Report

Devices descending from K954524

8 later devices reach W-55 (Methafilon a) Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992010W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear)…Westcon Contact Lens Co., Inc.19997—
+2K031774Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc.20045—
+2K011577Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and Thin Zone…Ocu-Ease Optical Products, Inc.20010—
+3K043540Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc.20054—
+4K080686Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co.20080—
+4K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts20072—
+5K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+6K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—