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510(k) Data Aggregation

    K Number
    K012298
    Device Name
    THE INTUITIVE COLORIMETER
    Date Cleared
    2001-09-26

    (68 days)

    Product Code
    Regulation Number
    886.1160
    Why did this record match?
    Product Code :

    NFD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Spectacle Lens Tint Color Selector is an AC powered device that is a variable-color illuminator intended to simulate vision through different colors of spectacle lens tints for the purpose of selecting preferred tint(s).
    Device Description
    A spectacle Lens Tint Color Selector is an AC powered device that is a variable illumination box intended to simulate vision through different colors of spectacle lens tints for the purpose of selecting preferred tint(s). The device is a variable color illuminator and is intended as an aid in the selection of tinted spectacle coatings. It provides illumination that simulates visual perception through various colors of tinted spectacles. The Intuitive Colorimeter uses light produced by a fluorescent tube, and the light is passed through a filter drum composed of seven colored filters consist of the 7 positions. The light is then viewed through a window in the instrument. When the drum is moved or rotated, the light becomes colored. Neutral density filters can adjust the luminance. Thus there are four calibrated controls, one for hue (color), one for saturation (depth), and one for the neutral density filter, plus a control that permits white fluorescent light to be substituted, for the purpose of base line evaluation.
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