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510(k) Data Aggregation

    K Number
    K000192
    Device Name
    E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
    Manufacturer
    MARTIN URAM, MD
    Date Cleared
    2000-04-10

    (81 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARTIN URAM, MD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K974878
    Device Name
    E3 MICROPROBE
    Manufacturer
    MARTIN URAM, MD
    Date Cleared
    1998-03-27

    (87 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARTIN URAM, MD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Contact and non-contact excision, hemostasis, incision and vaporization for the following soft tissue applications: General Surgery Ophthalmology / Oculoplastic Urology Gastroenterology Gynecology Otorhinolaryngology Pulmonary / Thoracic Dermatology / Plastic Surgery Neurosurgery Orthopedic
    Device Description
    The Endo Optiks E3 MicroProbe System consists of a laser, endoscope, console and footpedal. The treatment laser is a solid state diode laser system operating at 810 nanometers ± 2 nanometers and continuous wave power of up to 60 Watts. A visible solid state diode laser operating at a nominal wavelength of 640 nm and a variable continuous wave output from 0 to 1.5 milliwatts is incorporated as an aiming device. The end of the endoscope consists of a 0.25 milimeter diameter fiberoptic for viewing, a 0.10 millimeter diameter fiberoptic for delivery of the laser energy and fiberoptics that transmit the illumination light. Laser energy is delivered via a single timed continuous wave pulse with the time preset at the operator console and the pulse initiated by the footpedal. Laser power is also preset at the console. The E3 MicroProbe is a modification to the maximum power output rating of the original MicroProbe. Labeling: The MicroProbe will be renamed (relabeled) the E3 MicroProbe. This change is being made to be consistant with the industry practice of designating a laser's power based on the output power at the laser port rather than that at the tissue site. There is no change in construction or performance of this device. Power Output: An additional model will be created by increasing the output power to produce the E3 MicroProbe. The same basic design is retained. The 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new model have been appropriately scaled, while the mechanical design and user interface remain unchanged.
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