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510(k) Data Aggregation

    K Number
    K024164
    Device Name
    COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT
    Manufacturer
    Date Cleared
    2003-02-12

    (57 days)

    Product Code
    Regulation Number
    886.5916
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRO OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.
    Device Description
    The ComfortKone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens materials (hybufocon A, filotocon A, pemufocon A). When placed on the human cornea, the Comfort Keratoconus Aspheric rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina. The Comfort Kone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The ComfortKone™ lens design begins with a spherical 4.0 mm ontic zone that fits the peak of the cone and provides for good visual acuity. The lens then thattens into the aspheric curve, which is considered the fitting curve of the lens. The aspheric curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. design finishes with two junctioniess peripheral aspheric curves to maintain alignment.
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