DevicePMAs@therightstef:P930016_S045 JSONTXT 11 Projects

Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio Indication System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) for Use: in patients: 1) with mixed astigmatism as measured by iDesign Advanced WaveScan Studio System where the magnitude of cylinder (1.0 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; 2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign Advanced WaveScan 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.; and c) 18 years of age or older, and with refractive stability (a change of <=1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).