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510(k) Data Aggregation

    K Number
    K080794
    Device Name
    POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    POLYVUE DISTRIBUTION, INC.
    Date Cleared
    2008-12-17

    (272 days)

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

    POLYVUE DISTRIBUTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    I-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. I-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 5.00 Diopters. Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily I-55 Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not aphakic persons with non-diseased eves that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.
    Device Description
    I-55 Single Vision, I-55 Toric and I-55 Multifocal (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The I-55 Single Vision Contact Lens is available in a single vision lens design, the I-55 Toric Contact Lens is available in a back surface design, and the I-55 Multifocal Contact Lens is available in a concentric lens design. The lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contain 55% water by weight. I-55, I-55 Toric and I-55 Multifocal initiation The Tenb Contain of hilic) Contact Lenses for Daily Wear are visibility tinted using Pigment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR § 74.3045.
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