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

    VivaScope System

    K Number: K180162 · Decision May 3, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    104

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    Basic Information

    Device Name
    VivaScope System
    K Number
    K180162
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Caliber Imaging & Diagnostics, Inc.
    Date Received
    January 19, 2018
    Decision Date
    May 3, 2018
    Product Code
    PSN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PSN Light Based Imaging

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