DevicePMAs@therightstef:P030008_S017 JSONTXT 11 Projects

Approval to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. the device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik):1) for the reduction or elimination of up to -9.00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 d of spherical component and up to -3.00 d of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and3) in patients with documentation of a stable manifest refraction defined as 0.50 d or less of preoperative spherical equivalent shift over one year prior to surgery.