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510(k) Data Aggregation

    K Number
    K250131
    Device Name
    IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
    Date Cleared
    2025-03-19

    (61 days)

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

    Mustech Electronics Co., Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
    Device Description
    IPL Hair Removal Device is an over-the-counter, home use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, removing hair growth with minimal pain. The device includes 12 models, they are M8011, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023. Those models with model name of "M80XX" are equipped with cooling function for a better hair remove experience, while those of "M70XX" have no cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the light outlet is not in full contact with the skin, the device cannot emit light pulses.
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