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510(k) Data Aggregation

    K Number
    K080043
    Device Name
    VIZILITE EYEWEAR
    Manufacturer
    ZILA, INC.
    Date Cleared
    2008-04-04

    (87 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZILA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViziLite Eyewear is reusable and intended to be an optional accessory worn by health care professionals during chemiluminescent oral exam. INDICATIONS FOR USE: The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
    Device Description
    The ViziLite Eyewear is reusable polarized filtered eyewear that is worn by a health care professional to reduce the effects of ambient light during chemiluminescent oral exam when a darkened room is not available. The ViziLite Eyewear has been designed to allow transmission of 430-580nm light.
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