510(k) Report

Devices descending from K992950

2 later devices reach Custom Prosthetic (Hefilcon a) Soft Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041700Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily WearCantor & Nissel, Ltd.20040—
+1K020690Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc.20020—