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Home » Syneron lands FDA nod for “me” home-use hair removal system

Syneron lands FDA nod for “me” home-use hair removal system

October 19, 2012 By MassDevice staff

Syneron logo

Global aesthetic device manufacturer Syneron Medical (NSDQ:ELOS) landed FDA clearance to market its home-use hair removal system, named "me", directly to consumers. 

The "me" system, featuring Syneron’s proprietary elos energy technology, is the 1st and only FDA-cleared consumer hair removal technology indicated for all skin tones, according to the company.

"Gaining FDA clearance for the’ me’ home-use hair removal system is a significant milestone for Syneron," CEO Louis Scafuri said in prepared remarks. "It represents the 1st 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."

Syneron’s elos technology combines the power of intense pulse light and radio frequency energies to achieve a high level of safety and comfort with low optical energy output, the company said.

The “me” system is CE Marked in the European Union and approved by Health Canada. It has been available in several European markets since 2011.

Syneron expects its subsidiary Syneron Beauty to launch "me" systems in the U.S. through prestige retailers and directly to consumers starting in the 1st quarter of 2013, according to the press release.

That’s more good new for the device maker, which earlier this year won FDA clearance for its elos Plus multi-platform aesthetic device.

Syneron shares opened today at $9.53 and were up 0.8% to $9.59 as of about 3:45 p.m.

Filed Under: 510(k), Cosmetic/Aesthetic, Food & Drug Administration (FDA), News Well Tagged With: Syneron Medical Ltd.

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