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

    DUALENZ LOW VISION EYEWEAR

    K Number: K864594 · Decision Jan 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    60

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    Basic Information

    Device Name
    DUALENZ LOW VISION EYEWEAR
    K Number
    K864594
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5870
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Global Eye Care, Inc.
    Date Received
    November 21, 1986
    Decision Date
    January 20, 1987
    Product Code
    HKK
    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
    HKK Telescope, Spectacle, Low-Vision

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