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

    CLAS PHOTOKERATOSCOPE

    K Number: K895741 · Decision Jul 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    18
    Same Product Code
    28
    Applicant Total
    1
    Review Days
    288

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    Basic Information

    Device Name
    CLAS PHOTOKERATOSCOPE
    K Number
    K895741
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Kera-Metrics Corp.
    Date Received
    September 26, 1989
    Decision Date
    July 11, 1990
    Product Code
    HLQ
    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
    HLQ Keratoscope, Ac-Powered

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