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510(k) Data Aggregation

    K Number
    K161849
    Device Name
    Bright
    Manufacturer
    Tanda Beauty Canada Inc.
    Date Cleared
    2016-07-29

    (24 days)

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

    Tanda Beauty Canada Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bright device is intended to be used for the treatment of wrinkles, rhytides and fine lines in the periorbital region.
    Device Description
    The Bright is an over-the-counter device that uses light emitting diodes to emit red light (660 nm) during treatment. The device includes a control unit, a treatment surface and a protective cap that fits over the treatment surface area of the device when not in use. The device controls consist of a single on/off activation button. The rechargeable battery included in the device can be charged using a USB cable that is supplied.
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