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This article was originally published in The Gray Sheet

Executive Summary

Ophthalmic laser gains expanded FDA approval for treatment of hyperopic astigmatism using photorefractive keratectomy (PRK). The firm's premarket approval application supplement, covering hyperopia up to 5 D with astigmatism up to 4 D, was recommended for approval by FDA's Ophthalmic Devices Panel in May. The firm received approval in late 1999 for laser-assisted in situ keratomileusis (Lasik) treatment of myopia up to 12 D with or without astigmatism of up to 4 D. Alcon Summit Autonomous' LADARVision gained agency approval Sept. 22 for Lasik treatment of hyperopia up to 6 D, with or without astigmatism up to 6 D, and mixed astigmatism
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