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510(k) Data Aggregation

    K Number
    K153389
    Device Name
    Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
    Manufacturer
    IN LIGHT WELLNESS SYSTEMS, INC.
    Date Cleared
    2016-03-30

    (128 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    IN LIGHT WELLNESS SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To: 1) temporarily relieve minor pain, stiffness and muscle spasms; and 2) temporarily increase the local blood circulation.
    Device Description
    Elysiom™ Polychromatic LED Light Therapy (PLLT) System is a pulsed light emitting diode (LED) device providing a temporary increase in local circulation and temporary relief of minor pain. The LED lights provide gentle warmth. Elysiom™ uses a unique timed sequence of emissions, known as pulses, to create an environment in which change occurs regularly and rapidly.
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