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510(k) Data Aggregation

    K Number
    K053473
    Device Name
    MAESTRO MDTL LASER SYSTEM
    Manufacturer
    ADVANCED MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2006-02-03

    (51 days)

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

    ADVANCED MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums 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 promoting relaxation of muscle.
    Device Description
    The Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes. The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.
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    K Number
    K043353
    Device Name
    OMEGA EXCEL/XP LASER SYSTEM
    Manufacturer
    ADVANCED MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2005-07-01

    (207 days)

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

    ADVANCED MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omega Xp Laser System is indicated for use as an adjunctive treatment modality to provide temporary relief of pain associated with rotator cuff tendonitis.
    Device Description
    The Omega Xp Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by either AC or battery power and can be used with a variety of laser probes. The Omega Xp Laser System is intended to emit energy in the infrared spectrum to provide temporary relief of pain associated with rotator cuff tendonitis. The Omega Xp Laser System is comprised of a Base Unit and select Laser Probes. The Base Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Base Unit by an umbilical cord. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.
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