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510(k) Data Aggregation

    K Number
    K203510
    Device Name
    IPL Hair removal
    Date Cleared
    2021-02-26

    (88 days)

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

    Shenzhen Weikai Technology CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
    Device Description
    The IPL Hair removal is a personal, light-based, hair reduction device intended to be sold overthe-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The device consists of IPL main body and power adapter two parts, and treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp; and the device is power from power adapter via an external power. The IPL Hair removal includes V501, V201, V301-s, and V401 four models. Their intended use, performance, circuit principle, structure design and operation are basically identical, with the differences contains the appearance of the product , the size of PCB board and LCD display contents; and these differences do not affect or change the intended use of the device.
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