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510(k) Data Aggregation

    K Number
    K040871
    Device Name
    FACEMASTER FACIAL TONING SYSTEM
    Manufacturer
    FACEMASTER OF BEVERLY HILLS, INC.
    Date Cleared
    2005-06-01

    (425 days)

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

    FACEMASTER OF BEVERLY HILLS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FaceMaster Facial Toning System ("FaceMaster System") is intended to stimulate the face. The device is indicated for cosmetic use.
    Device Description
    The FaceMaster System is a transcutaneous electrical stimulator that incorporates a control module and two electrodes on separate, handheld probes to deliver electrical stimulation to the face muscles. The device is prepared for use by laying it flat on a table, opening the control module cover and removing the probes from their cradles inside the control module. Conductive solution is dispensed into a basin within the control module and, after placing the foam pads over the distal end of each probe the pads are soaked in the solution until they are moist. The user then pushes the power (ON/OFF) button to turn the device on and follows the instructions for use and the LCD and audible prompts from the control module to complete the three cosmetic stimulation modes, i.e., the eye cycle, the facial cycle, and the feathering cycle.
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