510(k) Report

Devices descending from K980554

4 later devices reach Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted…Alden Optical Labs., Inc.19983—
+2K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp.19992—
+3K041700Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily WearCantor & Nissel, Ltd.20040—
+3K020690Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc.20020—