DevicePMAs@therightstef:P150040_S003 JSONTXT 13 Projects

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 with or without astigmatism: 1) For spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters; 2) For cylinder from -0.75 diopters through -3.00 diopters; and3) When refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D in magnitude.