DevicePMAs@therightstef:P970005_S000 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P970005_S000","sourcedb":"DevicePMAs@therightstef","sourceid":"P970005_S000","text":"Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1)with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate a shift in refraction greater than 0.5D. 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