DevicePMAs@therightstef:P150040_S000 JSONTXT

Approval for the VisuMax Femtosecond Laser. This device is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >= -1.00 D to <= -8.00 D, with <= -0.50 D cylinder and MRSE <= -8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <= 0.50 D MRSE.