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    K Number
    K162489
    Device Name
    RED Light Device
    Manufacturer
    Zhongshan Bisen Plastic Electronic Products Co.,Ltd.
    Date Cleared
    2017-01-13

    (128 days)

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

    Zhongshan Bisen Plastic Electronic Products Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
    Device Description
    The proposed device, RED Light Device is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C. charging adapter. It is a hand held light emitting diode (LED) device for the treatment of periorbital wrinkles designed for home-use. The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.
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