510(k) Report

Devices descending from K121201

11 later devices reach Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors…St. shine Optical Co., Ltd.20167—
+1K132146Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd.20132—
+2K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation20204—
+2K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc.20181—
+2K172692Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily…Tangible Science, LLC20171—
+3K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color…Benq Materials Corporation20250—
+3K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20220—
+3K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20212—
+3K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable…Unicon Optical Co., Ltd.20190—
+4K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd.20241—
+5K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—