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510(k) Data Aggregation

    K Number
    K243036
    Device Name
    IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
    Manufacturer
    Bestway Plastic And Metal Products Ltd.
    Date Cleared
    2025-06-15

    (261 days)

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

    Bestway Plastic And Metal Products Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IPL Hair Removal Device is indicated for the 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, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed twenty-three models with the same IPL technology for hair removal, which is model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL20, BHRL-21, BHRL-22. The device 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. The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6±0.25cm² (Model BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-07, BHRL-08, BHRL09, BHRL-10) and 2.7±0.25cm² (Model BHRL-05, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-06, BHRL-06B, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22) that is suitable for multiple hair removal areas, such as large areas (e.g. face, arms, legs) and small areas (e.g. armpits, bikini line). The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function (except model: BHRL-06B), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
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