510(k) Report

Devices descending from K010114

24 later devices reach Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd.20160—
+1K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact LensSmart Performer Corp., Ltd.20160—
+1K073060Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.20071—
+1K062541Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20072—
+1K033969Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerVistakon20048—
+1K024177Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerJohnson & Johnson Vision Care, Inc.20039—
+1K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Vistakon200216—
+2K112373Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear ModificationInnova Vision, Inc.20120—
+2K062614Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility…Johnson & Johnson Vision Care, Inc.200673
+2K053191Discon Daily (Etafilcon a) One-Day Soft (Hydrophilic) Contact LensInnova Vision, Inc.20060—
+2K051900Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for…Johnson & Johnson Vision Care, Inc.2005142
+3K240918Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…Bruno Vision Care, LLC20241—
+3K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation20204—
+3K143280BHV VIVID (etafilcon A) Soft (Hydropholic) Contact LensBrien Holden Vision Pty, Ltd.20150—
+3K141917Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily WearUnicon Optical Co., Ltd.20143—
+3K141670Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc.20141—
+4K251683Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…Bruno Vision Care, LLC20250—
+4K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20220—
+4K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20212—
+4K172692Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily…Tangible Science, LLC20171—
+4K171125Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC20170—
+5K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd.20241—
+5K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable…Unicon Optical Co., Ltd.20190—
+6K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—