Visx Star S2
This article was originally published in The Gray Sheet
Executive Summary
Ophthalmic excimer laser vision correction system is approved by FDA for laser-assisted in situ keratomileusis treatment for up to -14 diopters of myopia with up to -5 D of astigmatism. The astigmatism range approved is slightly less than was sought in the CRS Clinical Research Inc.-sponsored premarket approval application; however, both the myopia and astigmatism ranges are broader than was recommended by FDA's Ophthalmic Devices Panel at a July 22 meeting. The PMA had sought treatments for up to -14 D of myopia with up to -6 D of astigmatism and the panel had recommended approval for correction of up to -12 D of myopia with astimatism of up to -4 D. The range approved is the same as that received Oct. 21 for Summit Technology's Apex Plus platform ("The Gray Sheet" Oct. 25, p. 14). Under Visx' deal with CRS, the approval was transferred to the company