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510(k) Data Aggregation

    K Number
    K171087
    Device Name
    AXON IR Heat Lamp
    Manufacturer
    Crystal Medtech, LLC
    Date Cleared
    2017-07-07

    (86 days)

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

    Crystal Medtech, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AXON IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
    Device Description
    The AXON IR Heat Lamp System is intended for use as a therapeutic heat lamp. The System is a non-invasive device that emits light energy to the skinsurface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The AXON IR Heat Lamp System deliver invisible laser light beams at 810 and 915 nm wavelengths using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic green laser guide light with 3 mW of power. TThe System consists of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable. The control consoles are made of standard medical PVC material and are designed to be placed in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display. The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of qlass suitable for medical applications.
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