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510(k) Data Aggregation

    K Number
    K161434
    Device Name
    Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
    Date Cleared
    2017-09-28

    (492 days)

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

    LI-TEK ELECTRONICS TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use. LED functional mode - To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face. - To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne. Vibrating massage functional mode As an electrically powered device intended for medical purposes to relieve minor aches and pains.
    Device Description
    Photon Vibrating massage Facial Aesthetic Device, Model: UI-200 is a device provided with two operation functions: Vibrating massage and LED light irradiation. The product provided with internal battery and it can be charged by external adaptor. For LED light irradiation functional, the device provides with two LED irradiation modes: Blue Light working Mode, Blue and Red Light working Mode, which can be switched by Mode button. When the device works in red and blue light working mode, the device provides spectral emission with LED red light (630±10nm) and blue light (415±10nm). In blue light working mode, the device only provide LED blue light output (415±10nm) by the LED lamp module in treatment head. When the device works in Vibrating massage mode, the vibration can be provided on the stainless steel contactor in treatment head and can provide vibrating massage to facial skin.
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