DevicePMAs@therightstef:P060004_S001 JSONTXT 11 Projects

Approval for the mel 80 excimer laser system. This device uses an optical zone of 6.0 to 6.5 mm in diameter and a transition zone of 2.0 to 4.0 mm for a total ablation diameter of 10.0 mm, and is indicated for primary laser assisted in situ keratomileusis (lasik) treatments for: 1) the reduction or elimination of naturally-occurring hyperopia of less than or equal to +5.0 d with or without refractive astigmatism of > +0.5 and <= +3.0d, with a maximum mrse of +5.0d; 2) in patients who are 21 years of age or older; and 3) with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of <= 0.5d.