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  • FDA-Approved Indications For Femtosecond Lasers

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    Juan Antonio Sanchez Broncano
    164 vizualizări1 pagină
    The document lists FDA-approved femtosecond lasers and their indications. Fourteen lasers are approved for creating corneal flaps in LASIK surgery or other treatments requiring initial lamellar resection of the cornea. Additional approved uses for some lasers include cataract surgery procedures such as anterior capsulotomy and laser phacofragmentation, lamellar and penetrating keratoplasty, and creating tunnels for corneal ring segments. The lasers are manufactured by companies including Carl Zeiss Meditec AG, IntraLase Corp., Alcon Laboratories, Inc., and Technolas Perfect Vision GmbH.

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    FEMTOLASER

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    FDA-Approved Indications for Femtosecond Lasers

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    The document lists FDA-approved femtosecond lasers and their indications. Fourteen lasers are approved for creating corneal flaps in LASIK surgery or other treatments requiring initial lamellar resection of the cornea. Additional approved uses for some lasers include cataract surgery procedures such as anterior capsulotomy and laser phacofragmentation, lamellar and penetrating keratoplasty, and creating tunnels for corneal ring segments. The lasers are manufactured by companies including Carl Zeiss Meditec AG, IntraLase Corp., Alcon Laboratories, Inc., and Technolas Perfect Vision GmbH.

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    Descărcați ca PDF, TXT sau citiți online pe Scribd
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    164 vizualizări1 pagină

    FDA-Approved Indications For Femtosecond Lasers

    Încărcat de

    Juan Antonio Sanchez Broncano
    The document lists FDA-approved femtosecond lasers and their indications. Fourteen lasers are approved for creating corneal flaps in LASIK surgery or other treatments requiring initial lamellar resection of the cornea. Additional approved uses for some lasers include cataract surgery procedures such as anterior capsulotomy and laser phacofragmentation, lamellar and penetrating keratoplasty, and creating tunnels for corneal ring segments. The lasers are manufactured by companies including Carl Zeiss Meditec AG, IntraLase Corp., Alcon Laboratories, Inc., and Technolas Perfect Vision GmbH.

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    TABLE 3 FDA-APPROVED INDICATIONS FOR FEMTOSECOND LASERS

    Model

    Company

    Indications

    FEMTO LDV (formerly Da Vinci


    Femtosecond Surgical Laser)
    (K053511; 3/10/06)

    Ziemer Ophthalmic Systems AG*


    (Port, Switzerland)

    In the creation of a corneal flap in patients undergoing LASIK


    surgery or other treatment requiring initial lamellar resection of the
    cornea.

    Horus Laser Keratome


    (K062314; 12/22/06)

    Carl Zeiss Meditec AG


    (Jena, Germany)

    In the creation of a corneal flap in patients undergoing LASIK


    surgery or other treatment requiring initial lamellar resection of the
    cornea.

    iFS Laser System


    (K073404; 4/25/08)
    (K113151; 3/8/12)

    Advanced Medical Optics, Inc.

    IntraLase Fusion Laser


    (K063682; 2/9/07)

    IntraLase Corp.

    IntraLase FS Laser, IntraLase


    FS30 Laser, Models 1,2,3
    (K060372; 8/16/06)

    IntraLase Corp.

    IntraLase FS Laser
    (K031960; 9/29/03)

    IntraLase Corp.

    Pulsion FS Laser Keratome


    (K013941; 2/27/02)

    IntraLase Corp.

    LenSx Laser System


    (K120732; 9/6/12)

    Alcon LenSx, Inc.


    (Aliso Viejo, CA)

    In the creation of corneal cuts/incisions, anterior capsulotomy and


    laser phacofragmentation during cataract surgery; each of these
    procedures may be performed either individually or consecutively
    during the same surgery; in the creation of a lamellar cut/resection
    for lamellar keratoplasty, and in the creation of a penetrating
    cut/incision for penetrating keratoplasty; in the creation of a corneal
    flap in patients undergoing LASIK surgery or other treatment
    requiring initial lamellar resection of the cornea.

    Technolas Femtosecond
    Workstation Custom Flap
    (formerly FemTec Laser
    Microkeratome)
    (K033354; 2/18/04)

    Technolas Perfect Vision GmbH

    In the creation of a corneal flap in patients undergoing LASIK


    surgery or other treatment requiring initial lamellar resection of the
    cornea.

    Victus Femtosecond Laser


    Platform
    (K120426; 7/31/12)

    Technolas Perfect Vision GmbH


    and Bausch & Lomb, Inc.
    (Rochester, NY)

    In the creation of a corneal flap in patients undergoing LASIK


    surgery or other treatment requiring initial lamellar resection of the
    cornea.

    VisuMax Laser Keratome


    (K100253; 7/8/10)

    Carl Zeiss Meditec AG


    (Jena, Germany)

    In the creation of a corneal flap in patients undergoing LASIK


    surgery or other treatment requiring initial lamellar resection of the
    cornea; in patients undergoing surgery or other treatment requiring
    initial lamellar resection of the cornea; in the creation of a lamellar
    cut/resection of the cornea for lamellar keratoplasty; in the creation
    of a cut/incision for penetrating keratoplasty and corneal
    harvesting.

    WaveLight FS200 Laser System


    (K101006; 10/21/10)

    Alcon Laboratories, Inc.


    (Fort Worth, TX)

    In the creation of a corneal flap in patients undergoing LASIK


    surgery or other surgery or treatment requiring 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 the creation of a corneal flap in patients undergoing LASIK


    surgery or other treatment requiring initial lamellar resection of the
    cornea; patients undergoing surgery or other treatment requiring
    initial lamellar resection of the cornea; patients undergoing surgery
    or other treatment requiring initial lamellar resection of the cornea
    to create tunnels for placement of corneal ring segments; in
    lamellar keratoplasty and corneal harvesting; in the creation of a
    lamellar cut/resection of the cornea for lamellar keratoplasty and in
    the creation of a penetrating cut/incision for penetrating
    keratoplasty; in patients undergoing ophthalmic surgery or other
    treatment requiring arcuate cuts/incisions, both penetrating and
    intrastromal.

    SOURCE: U.S. Food and Drug Administration. Available at: www.fda.gov. Accessed October 11, 2012.
    Adapted with permission from Farjo AA, Sugar A, Schallhorn SC, et al. Femtosecond lasers for LASIK flap creation; a report by the American Academy of
    Ophthalmology. Ophthalmology. In press.
    * Da Vinci application filed by SIE Ltd. Surgical Instrument Engineering.
    Advanced Medical Optics, Inc. acquired IntraLase Corp. 4/27/07; Abbott Laboratories, Inc. acquired Advanced Medical Optics, Inc. 2/26/09 and renamed the
    company Abbott Medical Optics, Inc., Abbott Park, IL.
    Since 2009, in joint venture with Bausch & Lomb, Inc., Rochester, NY; FemTec application was filed by 20/10 Perfect Vision Optische Gerate GmbH.

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