Device Dossier

Femtosecond ophthalmic Yb: Glass laser system

Device Dossier for Femtosecond ophthalmic Yb: Glass laser system (Femtosecond ophthalmic Yb: Glass laser system, Class IIb, sponsor AMO). ARTG record,…

Intended purpose

The ELITA™ Femtosecond Laser is an ophthalmic femtosecond laser intended for flapless refractive correction via lenticule creation and removal, which alters the curvature of the corneal surface so as to correct a patient’s refraction. It is indicated for the reduction or elimination of myopia with and without astigmatism. The ELITA™ Femtosecond Laser is also indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. It should only be operated by, or under the direct supervision of, a trained physician with certification in laser safety and in the use of ELITA™ for Smooth Incision Lenticular Keratomileusis (SILK™) treatments and corneal flaps.

TGA Public Summary