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510(k) Data Aggregation

    K Number
    K222432
    Device Name
    IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
    Manufacturer
    Hunan Guangye Biotechnology Co., Ltd.
    Date Cleared
    2022-10-11

    (60 days)

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

    Hunan Guangye Biotechnology Co., 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 (Model: KCA423, KCA437, KCA439), is an over-the-counter, homeuse and single-person-use 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 flash window and is suitable for multiple hair removal areas (such as: underarms, bikini lines, arms, legs, etc.). It contains a skin proximity 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. Models KCA437 and KCA439 have skin tone sensor to identify user's skin tone. Only user with suitable skin tone can use this device.
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    K Number
    K221151
    Device Name
    Beauty LED Mask, Model: KFB265
    Manufacturer
    Hunan Guangye Biotechnology Co., Ltd.
    Date Cleared
    2022-07-19

    (90 days)

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

    Hunan Guangye Biotechnology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
    Device Description
    The Beauty LED Mask adopts light emitting diodes (LED) in the red (637nm ± 5nm) + infrared (854nm ± 5nm) and blue (465 ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Beauty LED Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, Beauty LED Mask has incorporated protective eye-shield which blocks light energy from LEDs.
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