LaserSight's LaserScan 2000/LSX
This article was originally published in The Gray Sheet
Executive Summary
PMA is submitted for the scanning excimer laser platform. Data in support of the PMA were derived from a multicenter study evaluating use of the device to perform photorefractive keratectomy for treatment of myopia (nearsightedness) between -1.5 diopters and -10 D with less than or equal to 1 D astigmatism. LaserSight reports 1997 revenues (ended Dec. 31) of $24.4 mil, up 13% over 1996. Fourth-quarter revenues were flat at $6.3 mil. The company sells 13 laser systems in the fourth quarter, raising to 200 the total number of laser units sold to date