DevicePMAs@therightstef:P990027_S000 JSONTXT 11 Projects

Approval for the technolas(r) 217a excimer laser system. The devices is indicated to perform laser in-situ keratomileusis (lasik): 1) in treatments for the reduction or eliminatino of myopia (nearsightedness) from -1.00 to -7.00 diopters d with less than -3.00 d astigmatism; 2) in patients with documented stability of refraction for the prior 12 months as demonstrated by a change in manifest refraction of less than or equal to 0.5 d (in both cylinder and sphere components); and, 3) in patients 21 years of age or older.