510(k) Report

Devices descending from K963001

12 later devices reach Lifestyle 4-Vue (Polymacon) Hydrophilic Multifocal Contact Lens for Daily Wear through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971049Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Aspect Vision Care, Ltd.199711—
+2K042824Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact LensCooperVision, Inc.20045—
+2K984259Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Cl-Tinters19994—
+3K182674Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38…Largan Medical Co., Ltd.20181—
+3K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation20132—
+3K042435Cooper ProstheticCooperVision, Inc.20040—
+3K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp.19992—
+4K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20250—
+4K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd.20141—
+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—
+5K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20140—