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510(k) Data Aggregation

    K Number
    K980818
    Device Name
    POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)
    Manufacturer
    STEPHEN A. DUNN, INC.
    Date Cleared
    1998-03-30

    (27 days)

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

    STEPHEN A. DUNN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolyVue Silver Chord, Unisoft (methafilcon A) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism in not-aphakic persons with non-diseased eyes. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
    Device Description
    Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and methacrylic acid crosslinked with EGDMA, which yield the appearance of lenses, which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the comea and center over the apex of the cornea to provide corrective refraction of functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness), presbyopia and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Spherical and aspheric curves as well as beveled edge configurations are built into the lens for aiding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.
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    K Number
    K953807
    Device Name
    DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
    Manufacturer
    STEPHEN A. DUNN, INC.
    Date Cleared
    1996-02-14

    (190 days)

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

    STEPHEN A. DUNN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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