BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    LaserShot M, NaviLase

    K Number: K192008 · Decision Mar 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    240

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    Basic Information

    Device Name
    LaserShot M, NaviLase
    K Number
    K192008
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.6200
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitrolife GmbH
    Date Received
    July 29, 2019
    Decision Date
    March 25, 2020
    Product Code
    MRX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MRX System, Assisted Reproduction Laser

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