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510(k) Data Aggregation

    K Number
    K130065
    Device Name
    BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
    Manufacturer
    BIOSONIC TECHNOLOGIES, LLC
    Date Cleared
    2014-04-30

    (475 days)

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

    BIOSONIC TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Beautiful Image Model 900 Facial Toning Device uses microcurrent electrical energy to stimulate facial tissues for aestheric purposes. Biosonic Technologies Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face.
    Device Description
    Beautiful Image Model 900 Facial Toning Device is intended for facial stimulation and is indicated for prescription cosmetic use. The anatomical site for application of the Model 900 is the face. To enhance safety, the device is operated only from battery voltage and will not operate while connected to line power. A proper recharge should be performed prior to using the machine. The Model 900 is microprocessor controlled and housed in a white plastic case.
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