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510(k) Data Aggregation

    K Number
    K210376
    Device Name
    Superior Hair Remover
    Date Cleared
    2021-10-07

    (240 days)

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

    Guangzhou Haoxingwan Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Superior Hair Remover is an over the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    The Superior Hair Remover, an over-the-counter device, is a home-use device for the removal of unwanted hair from body parts. The device provides hair reduction using Intense Pulse Light(IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device can detect appropriate skin contact. 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. The device can flash for 300,000 times. The device is composed of a hand-held handle, a main unit, an external power cord, and eye protector, two attachable flash heads. It is used AC Powered (100-240V AC, 50/60Hz). The Superior Hair Remover includes T31 and T61 two models. Their indications for use, working principle, mode of action, operating mode, over-temperature protection function, structure design, button function, skin contact detection function, treatment area, spot size and operation are basically identical, with the minor differences contains product appearance, control buttons on touch panel, light intensity levels.
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