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510(k) Data Aggregation

    K Number
    K231215
    Device Name
    IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
    Date Cleared
    2023-06-26

    (59 days)

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

    ZhongShan Qizhe Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IPL Hair Removal device (Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S) is an Over the Counter device intended for the removal of unwanted body hair.
    Device Description
    IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S are a small over-the-counter device for the reduction of hair growth based on 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 powered by the external power adaptor or built-in battery and its IPL emission activation is by a switch or auto light emission. IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, contains a Xenon arc flashlamp, one built-in battery, a capacitive sensor to detect appropriate skin contact, and a skin color sensor to detect the skin color sensor is fixed in "Skin color recognition Window" of IPL Hair Removal device, and the device's skin color sensor automatically detects skin tone for your protection when the device is powered on. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone. The capacitive sensor is assembled in the device probe of IPL Hair Removal device, if the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. Based on the cooling technology, IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal. The IPL Hair Removal device, models: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S can be powered on built-in battery or cable adaptor. The built-in lithium battery can be recharged. When the capacity of battery is low, the battery icon " " " display red on the screen. When the When battery icon " t = " display red with blinking for about 20s the device will turn off. The recharge time of the battery is about 3 hours and when full charged and turn on level 5 to treatment the using time about 45 mins. When the device is turned on under battery-powered and insert the adaptor with the device, the device will be shut down and to charge. If you want to treatment, you shall turn on the device again with the cable adaptor. When device is turned on under cable adaptor, then take off the adaptor, the device will be shut down. If you still want to treatment, you shall turn on the device again. The IPL Hair Removal Device includes main unit (including built-in battery), an adaptor, goggles and shaver. The device is intended to be used for adults aged over 18. Principle of operation: Hair has a growth cycle, which can be roughly divided into incubation period, growth period and decline period. The growth period hair has a complete structure such as hair follicles and hair shafts. The hair in the incubation period and the decline period does not have the hair follicle structure. The removal of excess hair is to take advantage of the characteristics of the anatomical structure of hair. The device based on the IPL technology emits a specific wavelength of the light and delivers the light to the skin. It is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy below the surface of the skin, which disables the hair follicle preventing further growth. Therefore, the device achieves effective hair removal.
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