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SLT substantiates laser urologic claims questioned by FDA.

This article was originally published in The Gray Sheet

Executive Summary

SLT CAN RESUME PROMOTION OF LASER UROLOGIC CLAIMS QUESTIONED BY FDA in a Dec. 28, 1994 warning letter, Surgical Laser Tech-nologies reports Aug. 8. The company says that FDA has cleared a 510(k) including data to support the claims, which SLT had been making in promotional literature for several years. In the warning letter, FDA said that the claims had "not been substantiated to the agency."
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