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    K Number
    K243868
    Device Name
    Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2025-07-02

    (197 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K232649
    Device Name
    Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2024-05-08

    (251 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sphere and Asphere Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. Toric Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for the correction of refractive ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters. Multifocal Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. The lenses are intended for single-use disposable wear.
    Device Description
    The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19" and "Reactive Red 180" color additive, 21 CFR part 73.3121. Besides, Reactive Yellow 15, 21 CFR part 73.3121, is also used to reduce light in the range from 380 nm to 450 mm. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The lens reduces transmittance by less than or equal to 35% in the light range from 380 nm to 450 nm.
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    K Number
    K222885
    Device Name
    Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2023-05-31

    (250 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters. Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/ or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. The lenses are intended for single-use disposable wear.
    Device Description
    The Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).
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    K Number
    K211603
    Device Name
    Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2022-02-02

    (254 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Sphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition form +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters who may need up to +3.00 diopters of ADD power and have -3.50 diopters of astigmatism or less. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
    Device Description
    The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in sphere, asphere, toric, multifocal and multifocal-toric designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains a benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
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    K Number
    K211448
    Device Name
    Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2021-12-06

    (210 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myoropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters. Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25diopters and astigmatic corrections from -0.25 to -3.50 diopters. Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eve care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
    Device Description
    The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in spherical, aspherical, toric and multifocal designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. . The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR section 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin as a color indicator to induce the package solution as pink color.
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    K Number
    K200296
    Device Name
    Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2020-10-15

    (252 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pegavision (Etafilcon A) Color SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 dioters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye. Pegavision (Etafilcon A) Color Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye. Pegavision (Etafilcon A) Color Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye. Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Pegavision (Etafilcon A) Color SPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye. Pegavision (Etafilcon A) Color Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye. Pegavision (Etafilcon A) Color Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading. addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye. Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
    Device Description
    Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal designs lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. The contact lens color additives use FDA approved colorants and combination pigmented area that will mask or enhance the apparent color of the eyes. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80. Sodium Hyaluronate and Polyethylene Glycol.
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    K Number
    K161739
    Device Name
    Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
    Manufacturer
    PEGAVISION CORPORATION
    Date Cleared
    2016-12-19

    (178 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    PEGAVISION CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses: Spherical and Aspherical Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. 2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses: Spherical and Aspherical Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
    Device Description
    Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.
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    K Number
    K140025
    Device Name
    AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2014-10-15

    (282 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric: Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal: Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric: Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. 2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement (Replacement Recommended Every 2 Weeks): Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric: Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal: Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric: Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. 3. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Spherical and Aspheric: NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric: NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal: NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric: NaturalVue (Etafilcon A)Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
    Device Description
    The Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and Natural/ue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are clear or visibility-tinted, containing a UV blocker and are available in a spherical, aspherical multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from Etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% Etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
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    K Number
    K123973
    Device Name
    AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2013-04-23

    (118 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.
    Device Description
    Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
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    K Number
    K120028
    Device Name
    AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
    Manufacturer
    Pegavision Corporation
    Date Cleared
    2012-04-17

    (104 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegavision Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. The lens is intended for single-use disposable wear. 2. PEGAVISION Aquamax (Etafilcon A) Bi-weekly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.00D to -12.00D. The lens is intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
    Device Description
    Aquamax (Etafilcon A) Bi-Weekly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with ethylene glycol dimethacrylate (EGDMA) and 1.1.1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for These lenses contain UV blocker, a benzotriazole UV absorbing monomer handling. to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 30% in the UVA range of 315-380mm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
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