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510(k) Data Aggregation

    K Number
    K004049
    Device Name
    POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS)
    Manufacturer
    OPTECH, INC.
    Date Cleared
    2001-05-23

    (145 days)

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

    OPTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982110
    Device Name
    POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR
    Manufacturer
    OPTECH, INC.
    Date Cleared
    1998-11-06

    (143 days)

    Product Code
    LPL, 86L
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibility tinted) Is Indicated for dally wear for the correction of refractive ametropia (myopla and hyperopia), presbyopia and astigmatism In aphakic and non-aphakic persons with non-diseased eyes. Eyecare practitioners may prescribe the lens for dally 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 eyc. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refi action of functional conditions of the eye including myopla (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 alding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration.
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