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510(k) Data Aggregation

    K Number
    K163137
    Device Name
    NIRA Beauty Skin Laser
    Manufacturer
    Dermal Photonics Corporation
    Date Cleared
    2017-07-12

    (245 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dermal Photonics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIRA Beauty Skin Laser is indicated for the treatment of periorbital wrinkles.
    Device Description
    The NIRA Beauty Skincare Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging).
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