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510(k) Data Aggregation

    K Number
    K120511
    Device Name
    AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
    Manufacturer
    LETO ENTERPRISE LTD.
    Date Cleared
    2012-07-30

    (160 days)

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

    LETO ENTERPRISE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ageless Wonder Facial Toning Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. The anatomical site for application of the Ageless Wonder Facial Toning Device is the face.
    Device Description
    The Ageless Wonder Facial Toning Device is a battery-powered portable EMS device. It applied specially designed bi-polar low voltage micro-current impulses on the face. Not for use on injured or otherwise impaired skin or muscles, or use in any therapy or for the treatment, diagnosis, prevention or cure of any medical conditions or diseases. The device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper
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