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510(k) Data Aggregation

    K Number
    K984219
    Device Name
    COLORMAX COLOR VISION ENHANCEMENT LENSES
    Manufacturer
    COLOR VISION TECHNOLOGIES, INC.
    Date Cleared
    1999-11-18

    (358 days)

    Product Code
    NAI
    Regulation Number
    886.5844
    Why did this record match?
    Product Code :

    NAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ColorMax Lenses are indicated for use as an optical aid for Deutan and Protan color vision deficiencies.
    Device Description
    ColorMax Lenses are colored prescription spectacle lenses that are designed to aid color discrimination performance for those with Deutan and Protan color vision deficiencies. ColorMax Lenses are designed for binocular use. Use of this product may enhance the discrimination of certain colors and may reduce the discrimination of certain colors. This product is not a cure for color vision deficiencies or colorblindness.
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