BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLARUS

    K Number: K181444 · Decision Jan 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    29
    Review Days
    223

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    Basic Information

    Device Name
    CLARUS
    K Number
    K181444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carl Zeiss Meditec, Inc.
    Date Received
    June 1, 2018
    Decision Date
    January 10, 2019
    Product Code
    QER
    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
    QER Camera, Ophthalmic, Slit-Scanning

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