BEUDAMED
    Product Code: QQF FDA not classified

    Skin Microneedling Manual/Automated Device (Export Only)

    Unknown

    The Skin Microneedling Manual/Automated Device (Export Only) is a surgical device for one-time use by qualified clinical professionals intended to cause bio-active effects in the skin for aesthetic improvement, marketed exclusively for export and not legally marketed in the United States. It is unclassified for domestic use, with no regulation number assigned, and is reviewed by the General and Plastic Surgery panel. Product code QQF. The device is not an implant and is not life-sustaining.

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

    Basic Information

    Product Code
    QQF
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    SU
    Submission Type
    3

    Device Characteristics

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

    Definition

    For one-time (1X) use by qualified clinical professionals to cause bio-active effect(s) in skin for aesthetic improvement.

    Unclassified Reason

    3

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.