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SUMMIT TECHNOLOGIES' EXCIMER LASER PROMOTIONAL VIOLATIONS

This article was originally published in The Gray Sheet

Executive Summary

SUMMIT TECHNOLOGIES' EXCIMER LASER PROMOTIONAL VIOLATIONS alleged by FDA in an Oct. 27 warning letter to the company. The warning letter cites three violative situations regarding promotion of the excimer laser, one involving the sale of the device. The laser has not yet been approved by FDA, but the agency's Ophthalmic Devices Panel has recommended approval for both photorefractive keratectomy ("The Gray Sheet" Oct. 24, p. 3) and phototherapeutic keratectomy ("The Gray Sheet" March 28, p. 13).
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