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510(k) Data Aggregation

    K Number
    K961560
    Device Name
    ECLIPSE 2000
    Manufacturer
    Date Cleared
    1997-01-27

    (291 days)

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

    CARDIOGENES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Eclipse 2000™ is intended for use in general surgery, including thoracic and abdominal surgeries. This includes the incision, excision, vaporization or coagulation of soft tissue and firm cartilage: - . cholecystectomy - lysis of adhesions . - herniorrhaphy . - sessile polyps of the intestine and colon . - hemorrhoidectomy . - condyloma . - appendectomy ●
    Device Description
    The Eclipse Model 2000™ laser system is designed to be easy to operate and userfriendly. It features a security keyswitch and simple one-button start-up. Energy output is controlled by the Power thumbwheel adjustment. Energy is delivered through the Eclipse delivery system only when: - 1) the laser is in Ready mode, - 2) the Foot Pedal is depressed, and - 3) the delivery system is properly installed in the laser aperture. A variety of disposable fiber optic delivery systems in a range of sizes, designs and configurations is available from Eclipse. A fiber optic delivery system must be used to delivery laser energy to the treatment site.
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    K Number
    K955006
    Device Name
    ECLIPSE 2100
    Manufacturer
    Date Cleared
    1996-01-17

    (77 days)

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

    CARDIOGENES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    Ask a specific question about this device

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