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.

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.

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.

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.