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510(k) Data Aggregation

    K Number
    K213020
    Device Name
    IPL hair removal machine
    Date Cleared
    2021-12-16

    (87 days)

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

    Shenzhen Borria Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IPL hair removal machine is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
    Device Description
    The BR2020 IPL hair removal machine is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the treatment window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.
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