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Visx meeting with FDA to discuss Star PRK laser's high myopia, astigmatism capacities.

This article was originally published in The Gray Sheet

Executive Summary

VISX STAR PRK LASER SOFTWARE WITH HIGH MYOPIA, ASTIGMATISM CAPABILITY was part of the Star photorefractive keratectomy laser system approved by FDA March 27 although the agency did not approve the two indications, Visx maintains. Visx' statement responds to Summit allegations, spelled out in a June 24 letter to FDA, that by providing software capable of treating high myopia and astigmatism, Visx is "intentionally distributing unapproved devices."

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