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Sunrise Technologies

This article was originally published in The Gray Sheet

Executive Summary

Final PMA module for the Sunrise LTK laser thermal keratoplasty system to treat hyperopia of +0.75 to +2.5 diopters is submitted. The modular PMA includes data from 345 cases treated at eleven U.S. sites. The results "meet or exceed target endpoints set forth by the FDA draft guidance document for the treatment of hyperopia by refractive surgery lasers," the firm maintains

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