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510(k) Data Aggregation

    K Number
    K210545
    Device Name
    Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
    Manufacturer
    Marci Beauty Inc
    Date Cleared
    2022-05-20

    (449 days)

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

    Marci Beauty Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.
    Device Description
    The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution. 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 treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.
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