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Lumenis

This article was originally published in The Gray Sheet

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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