Laserscope Gets FDA Clearance for Pseudo-Folliculitis
SAN JOSE, Calif., Feb. 16 -- Laserscope has received clearance from the US Food and Drug Administration to market its Lyra long-pulse Nd:YAG laser system for the treatment of pseudo folliculitis, which is the inflammation or superficial infection of the hair follicle. It is often the result of injury or damage to the hair follicle caused by shaving or friction from clothing. Pseudofolliculitis barbae, commonly referred to as shaving bumps, razor bumps or ingrown hairs, is a condition occurring primarily in men and women of African or Middle Eastern descent.
"We are very excited to be the first and only company to have been granted marketing clearance by the FDA for the treatment of PFB," said Eric Reuter, Laserscope president and CEO. "We believe our clinical results are unmatched by any other technology or treatment modality currently available and having FDA clearance to market for this indication adds another potent application to this multispecialty laser system. Since there are no other known effective ways to address this condition, we believe that many people who suffer from it will seek treatment when they are made aware that it is available."
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