510(k) Report

Devices descending from P780007

7 later devices reach Hydron Hydrophilic Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd.20141—
+1K013220HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc.20014—
+2K142766I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc.20150—
+2K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20140—
+2K020608HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Poly Vue Technolgies, Inc.20022—
+3K221517POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft…INTEROJO, Inc.20221—
+4K242855P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)E.O.S Co., Ltd.20250—