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510(k) Data Aggregation

    K Number
    K051186
    Device Name
    MICROPULSE PHACOEMULSIFICATION SYSTEM
    Date Cleared
    2005-08-18

    (101 days)

    Product Code
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRILLIUM MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Phacoemulsification/extraction with ultrasonic power of cataractous lens from the eye.
    Device Description
    The MicroPulse Phacoemulsification Console and foot switch, with third party accessories, will emulsify a cataractous lens and remove it from the eye, using the same technology that the predicate devices employ by using ultrasonic power. The MicroPulse Phacoemulsification Console modes of operation are similar to the predicate devices such as: Diathermy (Coagulation), U/S Phaco, Irrigation/Aspiration (I/A) and Vitrectomy. The component parts of the MicroPulse Phacoemulsification console include the console and foot switch. The U/S handpiece and tubing set are specified third party accessories. The Diathermy, Irrigation/ Aspiration, and Vitrectomy devices are universal type handpieces that are also considered additional third party accessories to the MicroPulse Phacoemulsification console. Trillium Medical will manufacture the console and foot switch only. Trilliums Distributers will add the third party accessories (see Exhibit B) to the console and foot switch to assemble a complete Phacoemulsification system.
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