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510(k) Data Aggregation

    K Number
    K171647
    Device Name
    BeneLife Premium Facial Treatment Pack, Model: QZ0701A
    Date Cleared
    2017-10-23

    (140 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Infinitus (China) Company Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The micro current stimulation mode is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The red light treatment function is intended for the treatment of periorbital wrinkles.
    Device Description
    The device consists of three parts: Main unit. Micro current treatment and LED red light treatment attachment. There are two treatment heads for their separate treatment function. The micro current treatment attachment (electrode head) is for micro current stimulation function mode; and the LED red light attachment head is for red light irradiation function mode. For Micro current stimulation mode: The device has two electrode connectors for facial stimulation by applying the electrical micro current to electrodes. The output waveform is regulated Voltage of Pulsed Biphasic and provided with 5 steps of output intensity. The device is designed with 5 LED lamps of white color to indicate the output current intensity level. The micro current stimulation requires the use of a conductive gel with FDA clearance during its treatment. For LED Red light irradiation function: The device can provide specific photon spectrum by LED for Red irradiation mode. The red light is intended for the treatment of periorbital wrinkles. In Red irradiation mode, the device utilizes Light Emitting Diodes to provide LED light to the body. The red light output is a visible light source of high spectral purity. The output wavelength of Red light is 660 +/- 5 nm, and its power density is about 80mW/ cm2. During the treatment, the user places the treatment head to periorbital area for the treatment of periorbital wrinkle. The LED red light attachment head includes a skin contact sensor that will not allow delivery of light when the treatment head is not contacted with the skin. When the device is in battery charging, it cannot be operated for treatment. The device is designed with battery status indicating by five pieces of LED lamp on the front of main body of the device: 1. When the device is turned on, numbers of these LED lamps on the front of main body will display with blue color for 3 seconds to indicate the batter power level. 2. When the battery power is low, the first indicator LED lamp on the front of main body illuminates in orange color. 3. Numbers of indicator of these LED lamps will be illuminated in blue color when the battery is in charging, and the number of lamp lighting up will be increasing based on the battery power status during charging. When the battery has been charged fully, the five LED lamps is all light up.
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