Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053511
    Device Name
    DA VINCI FEMTOSECOND SURGICAL LASER
    Manufacturer
    SIE LTD SURGICAL INSTRUMENT ENGINEERING
    Date Cleared
    2006-03-10

    (84 days)

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

    SIE LTD SURGICAL INSTRUMENT ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Da Vinci™ Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The Da Vinci™ Femtosecond Surgical Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the Da Vinci™ Femtosecond Surgical Laser is achieved through nonlinear absorption of infrared laser light and subsequent disintegration of tissue, created by focused ultrashort pulses which are delivered through a lens while fixating the eye under a vacuum. The complete Da Vinci™ Femtosecond Surgical Laser system consists of the following functional units: 1. Base Station (BS), integrating the Laser Unit, Fast Scan Unit (FS), and Fixed Mirror Articulating Arm (FMAA) 2. Handpiece (HP), integrating the Slow Scan Unit (SS) and the Cutting Lens 3. Accessories, comprising Suction Ring, Distance Foil, Vacuum Tube with Strainer and Handpiece Cover. The Da Vinci™ Femtosecond Surgical Laser is movable on four rollers. Two rollers can be locked by a mechanical brake. For movement inside the clinic, HP and FMAA can be locked in a secured transport position.
    Ask a Question

    Page 1 of 1