DevicePMAs@therightstef:P020050_S005 JSONTXT

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The device, as modified, will be marketed under the trade name allegretto wave eye-q excimer laser system and is indicated for laser assisted in situ keratomileusis (lasik) for: 1) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 diopters (d) at the spectacle plane in patients who are 21 years of age or older with documentation of a stable manifest refraction defined as \u003c=0.50 d of preoperative spherical equivalent shift over one year prior to surgery; and 2) the wavefront-guided (wfg) reduction or elimination of up to -7.00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 d of spherical component and up to 3.00 d of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as \u003c=0.50 d of preoperative spherical shift over one year prior to 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