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510(k) Data Aggregation

    K Number
    K020006
    Device Name
    DYNA INTRA-LIMBAL LENS
    Manufacturer
    LENS DYNAMICS, INC.
    Date Cleared
    2002-03-29

    (86 days)

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

    LENS DYNAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dyna Intra-Limbal Lens (enflufocon or hexafocon A) rigid gas permeable contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty. The lens may be disinfected using a chemical disinfection system.
    Device Description
    The Dyna Intra-Limbal Lens (enflufocon A) or (hexafocon A) rigid gas permeable spherical contact lens is intended for the correction of highly irregular comeas occurring naturally or from disease such as Pellucid Marginal Degeneration and keratoconus or from post surgery complications such as tilted grafts. The design is larger in diameter, with a 11.2 mm standard diameter that is sized to fit within the limbus. A spherical peripheral system is employed to insure maximum exchange of tears and adequate cleansing of the cornea from flushing action behind the lens. The lens material attributes and lens parameters are found in the package insert.
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