510(k) Report

Devices descending from K032340

33 later devices reach Vistakon (Galyfilcon a) Soft Contact Lens through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130342Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerSauflon Pharmaceuticals, Ltd.20132—
+1K073485Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc.200830—
+2K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact LensVizionfocus, Inc.20250—
+2K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B)…Visco Vision, Inc.20168—
+2K133740Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal…Sauflon Pharmaceuticals, Ltd.20140—
+2K133472Sauflon Clariti 1 Day with Tint (Toric/Multifocal)Souflon Pharmaceuticals, Ltd.20140—
+2K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Sauflon Pharmaceuticals, Ltd.2013617
+2K100349Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.201013—
+3K202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…CooperVision, Inc.20200—
+3K201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze…Visco Vision, Inc.20200—
+3K193399Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20201—
+3K191397OxySoft (olifilcon C) silicone hydrogel soft contact lensVisco Vision, Inc.20190—
+3K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…CooperVision, Inc.201831
+3K181349Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily…Visco Vision, Inc.20180—
+3K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc.20181—
+3K173958OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon…Visco Vision, Inc.20180—
+3K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total…Ciba Vision Corporation201212—
+4K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20260—
+4K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalAlcon Laboratories, Inc.20260—
+4K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color…Benq Materials Corporation20250—
+4K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact…Vizionfocus, Inc.20241—
+4K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…CooperVision, Inc.20240—
+4K232921DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…Alcon Laboratories, Inc.202321
+4K182782DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1…Alcon Laboratories, Inc.20190—
+4K182902Precision1Alcon Laboratories, Inc.201841
+4K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20182—
+4K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20184—
+5K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…Alcon Laboratories, Inc.20251—
+5K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…Alcon Laboratories, Inc.202321
+5K230785Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc.20233—
+5K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20200—
+5K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Alcon Laboratories, Inc.20182—
+6K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.20200—