Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032400
    Device Name
    LAFACI
    Manufacturer
    VISION PRO, L.L.C.
    Date Cleared
    2004-05-07

    (277 days)

    Product Code
    FYD
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISION PRO, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, fluid aspiration, and the delivery of micro filtered air to the surgical field.
    Device Description
    LaFaci™ Surgical System combines multiple functions commonly utilized during LASIK into a single hand piece allowing for the delivery of sterile balanced saline irrigation solution to the surgical field, fluid aspiration from the surgical field, delivery of micro-filtered air to the surgical field, and plume evacuation from the surgical field. All of these functions are generated and delivered from the LaFaci™ Surgical Cart to the LaFaci™ Handpiece through fourlumen surgical tubing. LaFaci™ Handpiece also provides manual ocular fixation, and provides a platform for the temporary placement of the corneal flap during ablation. In addition the platform can be manually pivoted over the corneal bed thereby providing a spatula means to reposition the flap onto the stromal bed. The LaFaci™ Surgical Cart accessories include an adjustable instrument tray, and handpiece tubing swing arm that provides sterile setup and operational efficiency during surgery. The LaFaci™ Surgical Cart disposable accessories include the LaFaci Handpiece Tubing Set (sterile) and the LaFaci Smoke/Fluid Evacuation Accessories (non-sterile).
    Ask a Question

    Page 1 of 1