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510(k) Data Aggregation

    K Number
    K120604
    Device Name
    K-LASER
    Manufacturer
    ELTECH S.R.L
    Date Cleared
    2012-05-25

    (87 days)

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

    ELTECH S.R.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Each device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
    Device Description
    The devices under submission are a family of laser that emits a beam of coherent light in either continuous wave or pulse mode at the wavelengths previously described. Each device is a table device, easy to transport, usable also without electrical net, thanks to a battery pack. It is composed of a touch screen for managing all the device functions, an emitter, an handpiece for the delivery of light, software and an on/off button to activate and deactivate the infrared emission.
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