DevicePMAs@therightstef:P930016_S057 JSONTXT 11 Projects

Approval for the STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio. This device is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients: 1) with myopia, with or without astigmatism, as measured by iDESIGN Refractive Studio System with spherical equivalent up to -8.00 D, and cylinder up to -3.00 D. 2) with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN Refractive Studio System refraction as follows: a) Spherical Equivalent: Magnitude of the difference is less than 0.625 D. b) Cylinder: Magnitude of the difference is less than or equal to 0.5 D. 3) in patients 18 years of age or older. 4) with refractive stability (a change of </= 1.0 D in manifest refraction spherical equivalent for a minimum of 12 months prior to surgery), and5) with wavefront capture diameter of at least 4 mm.