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510(k) Data Aggregation

    K Number
    K962911
    Device Name
    CONTACT LENS WITH COLOR ADDITIVE
    Manufacturer
    Date Cleared
    1996-11-29

    (128 days)

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

    CAL BIONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    We now intend to add a "visibility tint" to our daily wear lenses so that they can be seen more easily while being handled for cleaning. The parameters and indications for the tinted lenses are exactly the same as those approved by the FDA for our clear lenses.
    Device Description
    The material from which the lens will be manufactured is FDA approved methafilcon-A. When fully hydrated, the material has a 55% water content. This high water content soft (hydrophilic) contact lens material has been tested for performance, comfort and oxygen transmissibility. We intend to add to our contact lens blanks a small amount of a colorant approved by the FDA for use in contact lenses. The concentration of the colorant is within the range approved by the FDA for use of this colorant in lenses. The colorant concentration is so low that the finished contact lens appears to have just a very faint blue-green tint when held against a white background. The very faint tint of this lens does not change the apparent color of the wearer's eye. The processes and equipment used to manufacture the "visibility tint" blanks and lenses are identical to those used for our clear daily wear blanks and lenses. The addition of the colorant does not affect the material in any way except for the addition of a faint color.
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