510(k) Report

Devices descending from K963837

7 later devices reach Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031774Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact LensesWestcon Contact Lens Co., Inc.20045—
+1K023530Horizon 38 (Clear) and Horizon 38 Westint (Tinted)Westcon Contact Lens Co., Inc.20020—
+2K043540Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact LensesWestcon Contact Lens Co., Inc.20054—
+3K080686Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co.20080—
+3K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts20072—
+4K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+5K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—