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510(k) Data Aggregation

    K Number
    K240519
    Device Name
    Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
    Manufacturer
    Innova Vision Inc.
    Date Cleared
    2024-04-17

    (54 days)

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

    Innova Vision Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sphere/Asphere: Innova Vision Sphere and Asphere (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and 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: Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters. Multifocal: Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric: Innova Vision Multifocal Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with nondiseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters. Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is to be discarded after each removal.
    Device Description
    The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN). The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens contains C.I. Reactive Blue 247 (21 CFR Part 73.3100 ) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel (Hvdrophilic) Daily Wear Soft Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315mm - 380mm). The Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.
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    K Number
    K232139
    Device Name
    Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
    Manufacturer
    Innova Vision Inc.
    Date Cleared
    2023-11-16

    (121 days)

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

    Innova Vision Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sphere/Asphere: Innova Vision Sphere and Asphere (mifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and 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: Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters. Multifocal: Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuty. Multifocal Toric: Innova Vision Multifocal Toric (inifiloon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters. Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
    Device Description
    The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hvdrophilic) Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN). The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm). The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.
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    K Number
    K222954
    Device Name
    Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens
    Manufacturer
    Innova Vision Inc.
    Date Cleared
    2023-03-13

    (167 days)

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

    Innova Vision Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sphere/Asphere Innova Vision Sphere and Asphere (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and 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 acuty. Toric Innova Vision Toric (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and 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 Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters. Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Etafficon A) Soft (Hydrophilic) Contact Lens is to be cleaned. rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
    Device Description
    Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region. The properties of the lens are: Chord Diameter: 13.00 mm to 15.00 mm Center Thickness 0.080 mm to 0.580 mm Base Curve: 8.0 mm to 9.8 mm Power Range Sphere Power: -20.00 D to +20.00 D in 0.25 D steps Cylinder Power (Toric): -0.25 D to -2.25 D in 0.25 D steps Cylinder Axis (Toric): 10 degrees to 180 degrees in 10 degrees steps Multifocal Power: +0.25 D to +4.00 D in 0.25 D steps Specific Gravity: 0.98 to 1.12 Refractive Index: 1.400 plus or minus 0.005 Visible Light Transmittance: > 95% UVA (315 nm~380 nm) Absorbance < 30% UVB (285 nm~315 nm) Absorbance < 5% Surface Character: Hydrophilic Water Content: 58% plus or minus 2% Oxygen Permeability: 24 times 10 to the power of -11 (cm squared dot ml O2)/(sec dot ml dot mmHg) plus 20%
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    K Number
    K213119
    Device Name
    Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
    Manufacturer
    Innova Vision Inc.
    Date Cleared
    2022-05-13

    (228 days)

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

    Innova Vision Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sphere/Asphere Innova Vision Sphere and Asphere (Hioxifilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and 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 Innova Vision Toric (Hioxifilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and 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 Innova Vision Multifocal (Hioxifilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric Innova Vision Multifocal Toric (Hioxifilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters. Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.
    Device Description
    Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (59% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and glycerol methacrylate (GMMA) cross-linked with ethylene glycol dimethacrylate (EGDMA) via UV photo-polymerization. Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for handling and contains 2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 50% in the UVA region.
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    K Number
    K112373
    Device Name
    CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
    Manufacturer
    INNOVA VISION INC.
    Date Cleared
    2012-08-17

    (366 days)

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

    INNOVA VISION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or 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 contact lens may be disinfected using chemical (not heat) disinfection system.
    Device Description
    Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed glass vials containing sterile isotonic phosphate buffered saline solution.
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    K Number
    K083288
    Device Name
    DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
    Manufacturer
    INNOVA VISION INC.
    Date Cleared
    2009-09-03

    (300 days)

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

    INNOVA VISION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is indicated for daily wear for the correction of refractive ametropia in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eyecare professional. When prescribed for frequent/planned replacement wear. The contact lens may be disinfected using chemical (not heat) disinfection system.
    Device Description
    The Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is available as non-spherical fenses manufactured by spin-casting method. The model illuminated with high water content (58 %). `.te hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) Ind methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is tinted blue using C.I Reactive blue 19 to make the lens more visible for handling In the Discon Plus Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics for Discon Plus lens are less than 5% in the UVB range of 280nm - 315nm and less than 30% in the UVA range of 316nm - 380nm. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.
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    K Number
    K073060
    Device Name
    CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    INNOVA VISION INC.
    Date Cleared
    2007-11-29

    (30 days)

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

    INNOVA VISION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing , disinfection and scheduled replacement as prescribed by the eyecare professional.. When prescribed for frequent/planned replacement wear , The contact lens may be disinfected using chemical (not heat) disinfection system.
    Device Description
    Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.
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    K Number
    K062541
    Device Name
    CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
    Manufacturer
    INNOVA VISION INC.
    Date Cleared
    2007-06-07

    (281 days)

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

    INNOVA VISION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.
    Device Description
    Calaview Colors Soft (hydrophilic) Contact Lens are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 ± 1%). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Colors Contact lens contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.
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    K Number
    K053191
    Device Name
    DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS
    Manufacturer
    INNOVA VISION INC.
    Date Cleared
    2006-05-12

    (178 days)

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

    INNOVA VISION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Discon Daily (Etafilcon A) One-Day Soft (hydrophilic) Contact Lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for single-use daily disposable wear. The Discon Daily Lenses are not intended to be disinfected and should be discarded after a single use.
    Device Description
    Discon daily Contact Lens are available as non-spherical fenses manufactured by spin-casting method. The model illuminated with high water content (58 The hydrogel lens' material is a random copolymer composed of %). 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Daily Contact lens with visible tint is light tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam-sterilized in a validated autoclave.
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    K Number
    K051129
    Device Name
    DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    INNOVA VISION INC.
    Date Cleared
    2005-08-12

    (101 days)

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

    INNOVA VISION INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement. The contact lens may be disinfected using a chemical (not heat) disinfection system only.
    Device Description
    Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Discon Contact lens with visible tint is tinted blue using Reactive Blue Dye #19 to make the lens more visible for handling. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam-sterilized in a validated autoclave.
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