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510(k) Data Aggregation

    K Number
    K161428
    Device Name
    PerfectSmooth
    Manufacturer
    SHEN ZHEN COSBEAUTY CO.,LTD.
    Date Cleared
    2017-03-23

    (304 days)

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

    SHEN ZHEN COSBEAUTY CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PerfectSmooth 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 PerfectSmooth 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 IPL technology. And it consists of IPL base unit and AC adapter, and a detachable lamp cap located in the IPL base unit which is the source of optical radiation, namely a Xenon flashlamp. The device is power from AC adapter via an external power.
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