DevicePMAs@therightstef:P970053_S009 JSONTXT 11 Projects

Approval for the nidek ec-5000 excimer laser system. The device uses a 6.0 mm optical zone and a 9.0 mm treatment zone and is indicated for laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of hyperopia refractive errors from +0.5 to +5.0 d of sphere with or without astigmatic refractive errors from +0.5 to +2.0 d at the spectacle plane with manifest refraction spherical equivalent (mrse) of +5.0 d or less; 2) in patients 21 years of age or older; and 3) in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in mrse not greater than +/- 0.50 diopter.