Laserscope receives FDA clearance for permanent hair reduction for the Lyra Laser System

Laserscope recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its innovative Lyra Laser System for permanent hair reduction on patients with the full range of skin tones from Fitzpatrick Types I - VI.

The Lyra system was previously cleared by the FDA in August 1999 for various dermatological applications including leg veins and also was FDA cleared in March of 2000 for hair removal. Additionally, in April of 2001, the Lyra was the first medical device of any kind cleared by the FDA for the treatment of Pseudo-Folliculitis.

"We are very pleased to have received FDA clearance to market our Lyra for permanent hair reduction," said Eric Reuter, Laserscope President and CEO. "This most recent FDA clearance adds yet another compelling indication for our Lyra laser and further differentiates this product from the competition as the most versatile and innovative aesthetic laser on the market today. Permanent hair reduction is defined as a permanent reduction in the number of hairs that regrow after a treatment regime. Multiple treatments are usually required to achieve more than temporary removal of hair and only a few select lasers have been granted clearance by the FDA to market for permanent hair reduction."

"Not all aesthetic lasers are created equally," continued Reuter. "The Lyra's unique blend of the longest available wavelength, variable pulse duration and patented epidermal cooling technology are combined in a product that is not only efficacious but extremely safe for all skin types. The range of applications for which the Lyra is currently cleared gives the practitioner a number of treatment options with a single system and provides an outstanding value."

Laserscope designs, manufactures, sells and services on a worldwide basis an advanced line of medical laser systems and related energy delivery devices for the office, outpatient surgical center, and hospital markets. More information on Laserscope can be found on the Company's web site at www.laserscope.com.

Source: Laserscope

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