YOKNEAM, Israel, Oct. 18, 2012 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), www.syneron.com, the leading global aesthetic device company, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the me Home-Use Hair Removal System to consumers (OTC). This marks the first home-use product featuring Syneron's proprietary elos technology to be cleared by the FDA. Syneron expects its subsidiary, Syneron Beauty, will initiate the U.S. commercial launch of the me system through prestige retailers and directly to consumers during the first quarter of 2013.
The me system is the first and only FDA cleared consumer hair removal technology that is approved for all skin tones. The system's revolutionary patented elos technology combines the power of Intense Pulse Light (IPL) and Radio Frequency (RF) energies, allowing it to achieve superior results with lower overall optical energy output and the highest level of safety and comfort. It is CE Marked, approved by Health Canada, and has been commercially available in several European markets since 2011. More information on the me system is available at www.memyelos.com.
Louis Scafuri, Chief Executive Officer of Syneron Medical, said, "Gaining FDA clearance for the me home-use hair removal system is a significant milestone for Syneron. It represents the first home-use application of Syneron's proprietary elos technology in the U.S., where it is already broadly used in Syneron's professional aesthetic products by plastic surgeons, dermatologists and other professional providers."Fabian Tenenbaum, Chief Executive Officer of Syneron Beauty, said: "The me system is the only consumer hair removal technology that is approved for all skin tones, increasing the addressable consumer market and underscoring the technological advantages of our proprietary elos technology for home-use aesthetic products. The me system has been well received in Europe and we are confident that consumers in the U.S. will be similarly attracted to its strong efficacy and unmatched comfort and safety profile." Jerome M. Garden, M.D., Department of Dermatology, Northwestern University, stated, "The Company conducted a 100-patient clinical study, covering all skin colors, at four leading dermatologist sites in the U.S., using the me hair removal instrument. The data from the study supports efficacy across all skin tones and confirmed a significant safety profile." About Syneron Beauty Syneron Beauty is a pioneer in the design, development and distribution of sophisticated consumer home-use aesthetic devices and products. The Company's products are based on clinically proven technologies derived from the professional aesthetic device market, enabling patients to achieve professional-like results in an at-home setting. Syneron Beauty currently markets the Tanda™ family of home-use light therapy and teeth whitening products and the me home-use hair removal system. The Company also has a home-use partnership with Procter & Gamble and several other new products in development. Syneron Beauty is based in New York, NY and is a wholly owned subsidiary of Syneron Medical Ltd. (NASDAQ: ELOS).