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Visx' Star is approvable for PRK, contingent on submission of additional data -- panel.

This article was originally published in The Gray Sheet

Executive Summary

VISX' STAR PRK APPROVABLE RECOMMENDATION CONTINGENT ON ADDITIONAL DATA submission to FDA as well as postmarket studies. The ophthalmic excimer laser should be approved by FDA for treating nearsightedness with photorefractive keratectomy if the requirements are met, the agency's Ophthalmic Devices Panel recommended in a 7-1 vote at an Oct. 20 meeting in Gaithersburg, Maryland.
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