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510(k) Data Aggregation

    K Number
    K210311
    Device Name
    Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
    Manufacturer
    Shenzhen Mismon Technology Co., Ltd.
    Date Cleared
    2021-07-23

    (170 days)

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

    Shenzhen Mismon Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Home Use IPL Beauty Device 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 Home Use IPL Beauty Device 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. Of which, the Device includes MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6 and MELSYA-M7 six models. All have adopted the same structure design, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power. The difference of all models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of model MS-208B, MS212B and MELSYA-M6 is designed to 3.6cm², model MS-216B, MS-218B and MELSYA-M7 is designed to 3.0 cm2, as well as the energy density of the all models is in the range of 2.0~5.1J/cm².
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