BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    COLORMAX COLOR VISION ENHANCEMENT LENSES

    K Number: K984219 · Decision Nov 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    358

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    Basic Information

    Device Name
    COLORMAX COLOR VISION ENHANCEMENT LENSES
    K Number
    K984219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5844
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Color Vision Technologies, Inc.
    Date Received
    November 25, 1998
    Decision Date
    November 18, 1999
    Product Code
    NAI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NAI Lens, Prescription, Color Deficiency