DevicePMAs@therightstef:P980031_S000 JSONTXT

This device is indicated for the reduction or elimination of mild myopia (-2.00 to -3.00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0.50D for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1.00D or less.