Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K051184
    Device Name
    55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Date Cleared
    2005-07-01

    (53 days)

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

    UNITED CONTACT LENS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 55 SV (ocufilcon C) 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. The 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and 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. The 55 Toric (ocutilcon C) 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/or not aphakic persons with non diseased eyes. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
    Device Description
    The 55 SV, 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The 55 Contact Lens is available in a single vision lens design, the 55 Toric Contact Lens is available in a double slab-off back surface design and the 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (ocufilcon C) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). Lenses are tinted using the color additive Reactive Blue 19.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1