510(k) Report

Devices descending from K961103

9 later devices reach Benz 38 Clear & with Blue Visibility Tint through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023987Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted…Contamac, Ltd.20032—
+1K980554Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens…Alden Optical Labs., Inc.19984—
+1K973967AL-47 (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted…Alden Optical Labs., Inc.199701
+2K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd.20141—
+2K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted…Alden Optical Labs., Inc.19983—
+3K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20140—
+3K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp.19992—
+4K041700Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily WearCantor & Nissel, Ltd.20040—
+4K020690Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc.20020—