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510(k) Data Aggregation

    K Number
    K023791
    Device Name
    NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
    Date Cleared
    2003-01-10

    (58 days)

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

    SOFTFOCAL COMPANY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NuSoft Spherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity. The NuSoft Toric (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity. The NuSoft Aspherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D that does not interfere with visual acuity. The NuSoft Bifocal (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with non-diseased eves that are myopic, or hyperopic, and/or presbyopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity. NuSoft Soft Contact lenses may be disinfected with a chemical (not heat) disinfection system.
    Device Description
    NuSoft (ocufilcon B) Spherical, Toric, Aspherical and Bifocal Soft Contact Lenses for Daily Wear (lathe-cut, clear or visibility tinted)
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