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    K Number
    K200044
    Device Name
    SkinStylus SteriLock MicroSystem
    Manufacturer
    Esthetic Education LLC
    Date Cleared
    2020-04-10

    (93 days)

    Product Code
    QAI, OAI
    Regulation Number
    878.4430
    Why did this record match?
    Applicant Name (Manufacturer) :

    Esthetic Education LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
    Device Description
    The SkinStylus SteriLock® MicroSystem is a handheld device that creates microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles.
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