510(k) Report

Devices descending from K962804

97 later devices reach Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…Pegavision Corporation20166—
+1K140025Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation20142—
+1K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation201210—
+1K100349Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.201013—
+1K092852Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily…St. shine Optical Co., Ltd.20103—
+1K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc.200913—
+1K073485Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc.200830—
+1K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.200518—
+1K030167Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV BlockerClearlab Pte, Ltd.20036—
+1K020927Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensBausch & Lomb200226—
+1K991134Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with…Vistakon, Johnson & Johnson Vision Products, Inc.199920—
+1K980634Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Aspect Vision Care, Ltd.19987—
+2K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231—
+2K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation20204—
+2K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd.20180—
+2K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B)…Visco Vision, Inc.20168—
+2K150385NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc.20151—
+2K133472Sauflon Clariti 1 Day with Tint (Toric/Multifocal)Souflon Pharmaceuticals, Ltd.20140—
+2K132854Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily WearYung Sheng Optical Co., Ltd.20136—
+2K132146Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd.20132—
+2K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Sauflon Pharmaceuticals, Ltd.2013617
+2K123973Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation20132—
+2K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total…Ciba Vision Corporation201212—
+2K082883Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily WearI-See Vision Technology, Inc.20091—
+2K062541Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20072—
+2K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd.20065—
+2K053191Discon Daily (Etafilcon a) One-Day Soft (Hydrophilic) Contact LensInnova Vision, Inc.20060—
+2K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc.200513—
+2K994324Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV…Vistakon, Johnson & Johnson Vision Products, Inc.200017—
+3K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalAlcon Laboratories, Inc.20260—
+3K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc.20240—
+3K232921DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…Alcon Laboratories, Inc.202321
+3K220045TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)Dk Medivision Co., Ltd.20220—
+3K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20220—
+3K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20212—
+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—
+3K182782DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1…Alcon Laboratories, Inc.20190—
+3K182902Precision1Alcon Laboratories, Inc.201841
+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—
+3K180669Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20182—
+3K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc.20181—
+3K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20184—
+3K173958OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon…Visco Vision, Inc.20180—
+3K172692Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily…Tangible Science, LLC20171—
+3K173086NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc.20170—
+3K170286Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon…Largan Medical Co., Ltd.20170—
+3K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact LensSmart Performer Corp., Ltd.20160—
+3K143190Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensYung Sheng Optical Co., Ltd.20150—
+3K143052Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for…Yung Sheng Optical Co., Ltd.20143—
+3K132714Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and…Vision Science Co., Ltd.20141—
+3K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated20133—
+3K131208Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Bausch & Lomb, Inc.20139—
+3K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd.20083—
+3K073060Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.20071—
+3K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Vistakon200216—
+4K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20260—
+4K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…INTEROJO, Inc.20260—
+4K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color…Benq Materials Corporation20250—
+4K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…Alcon Laboratories, Inc.20251—
+4K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact…Vizionfocus, Inc.20241—
+4K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd.20241—
+4K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…CooperVision, Inc.20240—
+4K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd.20241—
+4K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…Alcon Laboratories, Inc.202321
+4K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd.20231—
+4K230954Samfilcon B Custom Contact LensBausch + Lomb, Incorporated20230—
+4K230785Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc.20233—
+4K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated20211—
+4K202036Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc.20200—
+4K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan…Clearlab SG Pte, Ltd.20190—
+4K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable…Unicon Optical Co., Ltd.20190—
+4K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated20180—
+4K181454DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus…Alcon Laboratories, Inc.20182—
+4K151918Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue…Bausch & Lomb, Incorporated20160—
+4K150630Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…Yung Sheng Optical Co., Ltd.20152—
+4K143632Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact…Bausch & Lomb, Incorporated20151—
+4K142384DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)Qualimed Srl20140—
+4K112373Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear ModificationInnova Vision, Inc.20120—
+4K102895One Day Flat PackMenicon Co, Ltd.20111—
+4K051900Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for…Johnson & Johnson Vision Care, Inc.2005142
+5K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…HOYA Lamphun, Ltd.20260—
+5K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—
+5K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd.20250—
+5K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact LensVizionfocus, Inc.20250—
+5K240918Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…Bruno Vision Care, LLC20241—
+5K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…Bausch & Lomb, Incorporated20230—
+5K202448DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalAlcon Laboratories, Inc.20200—
+5K141917Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily WearUnicon Optical Co., Ltd.20143—
+5K062614Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility…Johnson & Johnson Vision Care, Inc.200673
+6K251683Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…Bruno Vision Care, LLC20250—
+6K171125Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC20170—
+6K143280BHV VIVID (etafilcon A) Soft (Hydropholic) Contact LensBrien Holden Vision Pty, Ltd.20150—
+6K141670Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc.20141—