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510(k) Data Aggregation

    K Number
    K172909
    Device Name
    ELEVARE, PERFECTIO 4
    Manufacturer
    Omm Imports d/b/a Zero Gravity
    Date Cleared
    2018-06-07

    (255 days)

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

    Omm Imports d/b/a Zero Gravity

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
    Device Description
    The Elevare Plus is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and I/R spectrum for the treatment of wrinkles on the face. The system components include the handheld unit containing the LED array, 2 Li-ion rechargeable batteries, power adapter, charging cord, charging cradle and travel case. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
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