510(k) Report

Devices descending from K042824

5 later devices reach Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182674Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38…Largan Medical Co., Ltd.20181—
+1K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation20132—
+2K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd.20250—
+2K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd.20141—
+3K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20140—