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510(k) Data Aggregation

    K Number
    K222316
    Device Name
    IPL Hair Removal Device
    Manufacturer
    Shenzhen Goodwind Technology Development CO., LTD
    Date Cleared
    2022-09-28

    (57 days)

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

    Shenzhen Goodwind Technology Development CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
    Device Description
    The IPL Hair Removal 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 Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with ice compress function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use. The IPL Hair Removal Device includes ZHF-IPL-II and ZHF-IPL-III two models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly in product appearance and its spot size of the treatment window, output energy, and display form, but these differences do not affect or change the intended use of the device. The model difference is embodied in #1) the spot size of the ZHF-IPL-II is 3.6cm2 and the corresponding output energy is 2.6~4.4J/cm²; the spot size of the ZHF-IPL-III is 4.1cm² and the corresponding output energy is 2.4~3.7J/cm²; #2) the display form of ZHF-IPL-II is LCD display screen and indicator light, and the display form of ZHF-IPL-III is indicator bar and light.
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