10.19.12
Aesthetic device company Syneron Medical Ltd. has received 510(k) clearance from the US FSA to market its me Home-Use Hair Removal System to consumers. This marks the first home-use product featuring Syneron's proprietary elos technology to be cleared by the FDA.
Syneron said its Syneron Beauty subsidiary will initiate the commercial launch of the system through prestige retailers and directly to consumers during the first quarter of 2013.
The me system’s patented elos technology combines the power of Intense Pulse Light (IPL) and Radio Frequency (RF) energies. It is CE Marked, approved by Health Canada, and has been commercially available in several European markets since 2011. The technology has been broadly used in Syneron's professional aesthetic products by plastic surgeons, dermatologists and other professional providers.
According to Fabian Tenenbaum, CEO of Syneron Beauty, 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.”
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 said its Syneron Beauty subsidiary will initiate the commercial launch of the system through prestige retailers and directly to consumers during the first quarter of 2013.
The me system’s patented elos technology combines the power of Intense Pulse Light (IPL) and Radio Frequency (RF) energies. It is CE Marked, approved by Health Canada, and has been commercially available in several European markets since 2011. The technology has been broadly used in Syneron's professional aesthetic products by plastic surgeons, dermatologists and other professional providers.
"Gaining FDA clearance for the me home-use hair removal system is a significant milestone for Syneron,” said Louis Scafuri, CEO of Syneron Medical.
According to Fabian Tenenbaum, CEO of Syneron Beauty, 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.”
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.