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

    SER Pen Carain MicroSystem (MP1209SP)

    K Number: K253153 · Decision Oct 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    33

    Basic Information

    Device Name
    SER Pen Carain MicroSystem (MP1209SP)
    K Number
    K253153
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4430
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Su-Ko Technologies, LLC
    Date Received
    September 26, 2025
    Decision Date
    October 29, 2025
    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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    Other Clearances by Su-Ko Technologies, LLC

    K Number Device Name
    K241355 SER Pen Carain MicroSystem (MP1209SP)