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Lumenis

This article was originally published in The Gray Sheet

Executive Summary

Laser device manufacturer will supply additional information to FDA within two weeks to help the agency complete its review of a 510(k) submission for the ClearLight high intensity light acne treatment system, the Israeli firm announces April 29. Lumenis recently elected to stop clinical trials of a laser system for the treatment of excessive menstrual bleeding, following insufficient interim results (1"The Gray Sheet" April 15, 2002, In Brief)...

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