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510(k) Data Aggregation

    K Number
    K231073
    Device Name
    SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
    Manufacturer
    Esthetic Medical Inc.
    Date Cleared
    2023-07-28

    (105 days)

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

    Esthetic Medical Inc.

    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. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
    Device Description
    The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as 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. The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use. The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11.
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