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510(k) Data Aggregation

    K Number
    K073352
    Device Name
    WEBERNEEDLE BASIC LASER
    Manufacturer
    Date Cleared
    2008-08-11

    (256 days)

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

    WEBER MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The weberneedle@basic laser is indicated to provide topical heating for the following: - temporary increase of local blood circulation. - temporary relief of minor muscle and joint aches, pains, and stiffness. - temporary relaxation of muscles. - temporary relief of muscle spasms. - temporary relief of minor pain and stiffness associated with arthritis.
    Device Description
    The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are non-invasive, portable therapeutic medical laser systems designed to deliver light energy to the target tissue. The red and infrared lamps provide continuous heat therapy at a fixed frequency. The System operates by AC power and is used with 8 up to 12 faser modules, as standard 4 red and 4 infrared modules. The system consists of a Control Unit / Power Supply that houses the electronics and controls the power and varies the frequency of the each laser module. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are equipped with single fibre optics to bring the emitted energy to the tissue. That allows treatment either of small or of expanded pain areas as well as both at the same time.
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