DevicePMAs@therightstef:P030008_S006 JSONTXT

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{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P030008_S006","sourcedb":"DevicePMAs@therightstef","sourceid":"P030008_S006","text":"Approval for increased pulse frequency from 400 to 500 hz, a new laser head, a new housing with greater integration of accessories, modified laser pulse temporal parameters, new eyetracker, new scanner, remodeled user interface, addition of networking capability, andmodified software. the device, as modified, will be marketed under the trade name wavelight ex500 laser system and is indicated for laser assisted in situ keratomileusis (lasik) for: 1) the reduction or elimination of myopia of up to -12.0 diopters (d) of sphere and up to - 6.0 d of astigmatism 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 preoperativespherical equivalent shift over one year prior to surgery; 2) the reduction or elimination of hyperopic 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