510(k) Report

Devices descending from K040900

13 later devices reach S-42 UV, T-42 UV Toric and M-42 UV Multifocal (Hefilcon a) Soft (Hydrophilic)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150293EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear…I-See Vision Technology, Inc.20153—
+1K123484Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft…St. shine Optical Co., Ltd.20138—
+2K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)Vizionfocus, Inc.20250—
+2K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc.20182—
+2K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors…St. shine Optical Co., Ltd.20167—
+3K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation20204—
+3K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact LensesVizionfocus, Inc.20190—
+3K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc.20181—
+4K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color…Benq Materials Corporation20250—
+4K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20220—
+4K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20212—
+5K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd.20241—
+6K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—