BEUDAMED
    Product Code: QZN FDA class 2 21 CFR 878.4580

    Multi-Photon Imaging

    General, Plastic Surgery

    The multi-photon imaging device (product code QZN) is a Class 2 General, Plastic Surgery device (regulation 878.4580) intended to provide visible illumination of the surgical field or the patient during surgical procedures. It requires 510(k) clearance. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QZN
    Device Class
    FDA class 2
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    To provide visible illumination of the surgical field or the patient

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K232789 VIO System (V-1000)