LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K141476
    Device Name
    WAVELIGHT FS200 LASER SYSTEM
    Manufacturer
    ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.
    Date Cleared
    2014-09-30

    (118 days)

    Product Code
    OOE
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WaveLight FS200 Laser System is an ophthalmic surgical laser indicated for use: · In the creation of a corneal flap in patients undergoing LASIK surgery or treatment reguiring initial lamellar resection of the cornea. · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. · In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting. · In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea. · In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea.
    Device Description
    The WaveLight® FS200 is a stationary scanning-spot femtosecond laser system used to support refractive surgery of the cornea as specified in the indications for use statement.
    Ask a Question

    Page 1 of 1