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

    SkinStylus SteriLock® MicroSystem, Model Number MP1209SL

    K Number: K231073 · Decision Jul 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
    K Number
    K231073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4430
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Esthetic Medical, Inc.
    Date Received
    April 14, 2023
    Decision Date
    July 28, 2023
    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 Esthetic Medical, Inc.

    K Number Device Name
    K253002 SkinStylus SteriLock MicroSystem (MP1209SL)