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

    SkinPen Precision System

    K Number: DEN160029 · Decision Mar 1, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    604

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    Basic Information

    Device Name
    SkinPen Precision System
    K Number
    DEN160029
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4430
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Bellus Medical, LLC
    Date Received
    July 5, 2016
    Decision Date
    March 1, 2018
    Product Code
    QAI
    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
    QAI Powered Microneedle Device

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