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510(k) Data Aggregation

    K Number
    DEN160029
    Device Name
    SkinPen Precision System
    Manufacturer
    BELLUS MEDICAL, LLC.
    Date Cleared
    2018-03-01

    (604 days)

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

    BELLUS MEDICAL, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.
    Device Description
    The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen Precision) and a sterile needle cartridge (SkinPen Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen Precision System treatment kit is provided separately and contains the following: - SkinPen Precision Cartridge: sterile, disposable needle cartridge. Not to be . resterilized or reused. - . SkinPen BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen Precision - . Lift HG: hydrogel wound dressing (without drugs and/or biologics) to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure
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