Bausch & Lomb
This article was originally published in The Gray Sheet
Executive Summary
U.S. approval for the Keracor 116 excimer laser system for photorefractive keratectomy is announced Oct. 4. However, the company will forgo marketing and instead devote resources to the Technolas 217 for laser in situ keratomileusis, for which approval is anticipated by year-end. The Keracor 116 is indicated for correction of myopia of -1.5 to -7.0 diopters with up to -4.5 D of astigmatism. The device's use "will be limited to the investigational device exemption users originally recruited to perform the clinical studies," B&L says