510(k) Report

Devices descending from K062614

7 later devices reach Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation20204—
+1K143280BHV VIVID (etafilcon A) Soft (Hydropholic) Contact LensBrien Holden Vision Pty, Ltd.20150—
+1K141670Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc.20141—
+2K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20220—
+2K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20212—
+3K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd.20241—
+4K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—