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Hairy marketing

This article was originally published in The Gray Sheet

Executive Summary

Lexington International, maker of the HairMax LaserComb laser hair growth promoter, files an Aug. 13 1citizen petition accusing three competitors of marketing unapproved devices, and urges FDA to take enforcement action. According to the petition, GMR Products, Sunetics International and Bauman Medical Group sell hair-growth systems that are unapproved, do not meet quality systems standards, and are subject to false and misleading claims. FDA issued warning letters to Sunetics (Laser Hair Brush) and another laser stimulation company, Gaunitz Hair Sciences (THL-1 handheld laser), on Aug. 7 for marketing unapproved devices
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