510(k) Report

Devices descending from P820086

97 later devices reach Cibatint (TM) Tinting Process through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970746SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation199796—
+2K083921Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact LensSynergeyes, Inc.20091—
+2K073459Ciba Vision (Lotrafilcon B) Soft Contact LensesCiba Vision Corporation200817—
+2K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc.2005741
+2K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation200295—
+3K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20252—
+3K212806Alcon (serafilcon A) soft contact lenses for daily wearAlcon Laboratories, Inc.20210—
+3K210436Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30…Alcon Laboratories, Inc.20214—
+3K180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact LensMenicon Co, Ltd.20180—
+3K160245Visco (olifilcon A) soft contact lensVisco Vision, Inc.20160—
+3K160938SynergEyes SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear LensSynergeyes, Inc.20160—
+3K160609AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus…Alcon Laboratories, Inc.20160—
+3K153305EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL…Eyeyon Medical20160—
+3K160212ACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc.201651
+3K141348Visco Soft Contact LensVisco Vision, Inc.201512—
+3K141670Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc.20141—
+3K133740Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal…Sauflon Pharmaceuticals, Ltd.20140—
+3K133472Sauflon Clariti 1 Day with Tint (Toric/Multifocal)Souflon Pharmaceuticals, Ltd.20140—
+3K133176Air Optix Colors, Air Optix Colors Toric, Air Optix Colors MultifocalCiba Vision Corporation20142—
+3K130342Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerSauflon Pharmaceuticals, Ltd.20132—
+3K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Sauflon Pharmaceuticals, Ltd.2013617
+3K121519IsightC&E GP Specialists, Inc.20120—
+3K121324Avt NaturasoftAdvanced Vision Technologies20120—
+3K111267Concise, Silicone Hydrogel Daily Wear Soft Contact Lens (Efrofilcon a)Abbconcise Optical Group, LLC20110—
+3K100456Cvue Advanced DefinitiveUnilens Corp., USA20102—
+3K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.20101—
+3K100244Metro SoftMetro Optics of Austin, Inc.20108—
+3K100221INTELLIWAVE3Art Optical Contact Lens, Inc.201032—
+3K071736Aquair (Enfilcon a) Soft (Hydrophilic) Contact LensCooperVision, Inc.2008142
+3K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal DesignsCiba Vision Corporation2004941
+4K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—
+4K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation20260—
+4K251573VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact LensVizionfocus, Inc.20250—
+4K242391Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact LensLucens Technology Co., Ltd.20240—
+4K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company20240—
+4K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc.20240—
+4K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Metro Optics of Austin, Inc.20240—
+4K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…Alcon Laboratories, Inc.202321
+4K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231—
+4K230824IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)Art Optical Contact Lens, Inc.20232—
+4K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation20220—
+4K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensUnicon Optical Co., Ltd.20221—
+4K202756Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day…CooperVision, Inc.20200—
+4K191121Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for…Lentechs, LLC20190—
+4K181920Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…CooperVision, Inc.201831
+4K171447OxyPure Color Silicone Hydrogel Soft Contact LensesVisco Vision, Inc.20172—
+4K172600AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS MultifocalAlcon Laboratories, Inc.20171—
+4K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B)…Visco Vision, Inc.20168—
+4K142641Intelliwave4Art Optical Contact Lens, Inc.201512—
+4K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc.20140—
+4K133627Avaira Spheric and Toric (Enfilcon a) Soft Contact LensCooperVision, Inc.20130—
+4K131378Sus (Stenfilcon a) Contact LensCooperVision, Inc.2013105
+4K123120Lensx Laser SystemAlcon Lensx, Inc.20125—
+4K121652Cvue Advanced Hydra VueUnilens Corp., USA20120—
+4K113759Avaira (Enfilcon a) Contact LensCooperVision, Inc.201251
+4K113245Avaira Avaira Toric Avaira MultifocalCooperVision, Inc.20110—
+4K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens…Unilens Corp., USA20110—
+4K062262Ciba Vision (Sifilcon a) Spherical, Toric, Multifocal and Multifocal Toric DesignsCiba Vision Corporation20060—
+5K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color…Benq Materials Corporation20250—
+5K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…Alcon Laboratories, Inc.20251—
+5K242413VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact…Vizionfocus, Inc.20241—
+5K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™Unicon Optical Co., Ltd.20240—
+5K234127Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…CooperVision, Inc.20240—
+5K222500Air Optix ColorsAlcon Laboratories, Inc.20220—
+5K201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze…Visco Vision, Inc.20200—
+5K193399Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20201—
+5K191763MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…CooperVision, Inc.20202—
+5K191397OxySoft (olifilcon C) silicone hydrogel soft contact lensVisco Vision, Inc.20190—
+5K183670Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone…Visco Vision, Inc.20190—
+5K190965MyDayCooperVision, Inc.201914
+5K181349Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily…Visco Vision, Inc.20180—
+5K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc.20181—
+5K173958OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon…Visco Vision, Inc.20180—
+5K161288LenSX Laser SystemAlcon Laboratories, Inc.20164—
+5K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensCooperVision, Inc.201631
+5K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc.201511—
+6K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.20260—
+6K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalAlcon Laboratories, Inc.20260—
+6K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd.20241—
+6K220070MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…CooperVision, Inc.202205
+6K213164Avaira VitalityCooperVision, Inc.202111
+6K182249Ultra (samfilcon A) Multifocal for Astigmatism Contact LensBausch & Lomb, Incorporated20180—
+6K171125Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC20170—
+6K163551LenSx Laser SystemAlcon Laboratories, Inc.20173—
+6K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd.20168—
+7K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…HOYA Lamphun, Ltd.20260—
+7K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.20214—
+7K202860Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E…Valley Contax, Inc.20210—
+7K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+7K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…Paragon Vision Sciences20180—
+7K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd.20171—
+8K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+8K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc.20243—
+9K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—
+9K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc.20240—
+9K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.20240—
+9K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight20240—