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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Israeli firm elects to stop clinical trials of laser system for the treatment of excessive menstrual bleeding following the release of interim results that would not be sufficient to support an FDA marketing claim, Lumenis announces April 4. The company is currently working with FDA to modify the trial. A PMA submission was originally planned for the end of 2002, and the extent of the delay is still under evaluation...
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