Summit Technology
This article was originally published in The Gray Sheet
Executive Summary
Announces FDA approval to begin 425-patient, seven-site clinical study examining use of its excimer laser system for laser-assisted automated lamellar keratectomy (ALK) treatment of nearsightedness of up to 25 diopters. In the outpatient procedure, a "flap" of tissue is removed from the cornea. The excimer laser is used to make a refractive correction directly on the cornea or on the flap, which is then replaced in the eye. Summit has a premarket approval application pending for use of the excimer laser to treat nearsightedness of up to five diopters via photorefractive keratectomy