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In Brief: Kremer LASIK PMA

This article was originally published in The Gray Sheet

Executive Summary

Kremer LASIK PMA: Ophthalmologist and inventor Fredric Kremer's premarket approval application for single-site use of an excimer laser to perform Laser-K LASIK (laser in situ keratomileusis) procedures is scheduled for review by FDA's Ophthalmic Devices Panel on Feb. 13. Approval of the PMA, which encompasses treatment of myopia and myopic astigmatism at Kremer Laser Eye Center, in King of Prussia, Pennsylvania, would seal an agreement with LaserSight giving the company rights to the technology ("The Gray Sheet" Aug. 18, 1997, I&W-16). The Kremer PMA is not the first single-site LASIK PMA to go before the panel. In July 1997, the Ophthalmic panel unanimously recommended approval of a PMA from The Vision Correction Group, Atlanta ("The Gray Sheet" July 21, 1997, p. 10)...
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