dimarts, 29 de novembre del 2016

Cynosure wins Chinese FDA nod for Icon aesthetic system

CynoSureCynosure (NSDQ:CYNO) said today it won Chinese FDA clearance for its Icon aesthetic system, which is now cleared for multiple aesthetic indications.

The system is now cleared in China for facial vessel and pigment clearance, wrinkle reduction, hair removal and scar and stretch mark treatment, the Westford, Mass.-based company said.

“Cynosure was the 1st U.S. aesthetic laser company to establish a wholly owned subsidiary in China more than 10 years ago, and we continue to expand our competitive position in that country – and the entire Asia Pacific region – as part of our international growth strategy. Today, China is our largest subsidiary in the world. Gaining CFDA approval to market Icon there is another milestone as we strive to grow our APAC business at a pace ahead of the overall market. With strong customer relationships, an established direct sales force, and the rapid growth of medical aesthetics in China, we believe we are positioned to achieve that objective,” prez & CEO Michael Davin said in a press release.

The company said it plans to begin offering the Icon system in China during the 4th quarter of 2016.

In May, Cynosure said it won FDA 510(k) clearance for its 1064 nm PicoSure laser delivery system designed for tattoo removal.

The next-gen laser delivery system has improved multi-wavelength laser technology designed to remove the “full color spectrum of tattoo inks” in less treatments than previous versions, the Westford, Mass.-based company said.

The post Cynosure wins Chinese FDA nod for Icon aesthetic system appeared first on MassDevice.



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