510(k) Report

Devices descending from K020608

2 later devices reach HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…INTEROJO, Inc.20221—
+2K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd.20250—