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

    VIO System (V-1000)

    K Number: K232789 · Decision Dec 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    102

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    Basic Information

    Device Name
    VIO System (V-1000)
    K Number
    K232789
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enspectra Health, Inc.
    Date Received
    September 11, 2023
    Decision Date
    December 22, 2023
    Product Code
    QZN
    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
    QZN Multi-Photon Imaging