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510(k) Data Aggregation

    K Number
    K250253
    Device Name
    IPL Hair Removal Device (KCA511/KCA516/KCA522)
    Manufacturer
    Dongguan Boyuan Intelligent Technology Co.,Ltd
    Date Cleared
    2025-05-06

    (98 days)

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

    Dongguan Boyuan Intelligent Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    IPL Hair Removal Device (Model: KCA511, KCA516,KCA522), is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable treatment window and the spot size is 3.3cm² that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience. IPL Hair Removal Device, model: KCA511, KCA516 and KCA522 have the same indication for use, performance, structure design and operation, the only deference is their appearance size and weight. IPL Hair Removal is used for removing excess facial hair and body hair and can also reduce hair regrowth. The products can be used on body parts such as underarm, bikini line, arms, facial hair below the chin line, back and legs. It is designed so that the flash window requires full contact with the skin to work (flash),it will no works as long as the flash window does not contact the skin.
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    K Number
    K240282
    Device Name
    IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
    Manufacturer
    Dongguan Boyuan Intelligent Technology Co.,Ltd.
    Date Cleared
    2024-04-03

    (62 days)

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

    Dongguan Boyuan Intelligent Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Not Found
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