Date Announced: 15 Mar 2011
Canada Licenses SmoothShapes XV; Smartlipo Triplex Wins Korea FDA Approval.
WESTFORD, Mass., March 15, 2011 /PRNewswire/ -- Cynosure, Inc. (Nasdaq: CYNO), a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, today announced that two of its newest workstations for laser-assisted lipolysis and non-invasive cellulite reduction have received key international regulatory clearances.
Health Canada has issued a Medical Device License authorizing the sale in Canada of the company's SmoothShapes® XV system for the temporary reduction in the appearance of cellulite. The non-invasive SmoothShapes XV treats cellulite through a proprietary process known as Photomology®, which combines laser and light energy with mechanical manipulation (vacuum and massage) to produce tighter, smoother-looking skin.
Overseas, the Korea Food and Drug Administration has granted marketing approval to Cynosure's Smartlipo Triplex™, the company's minimally invasive technology for fat removal and skin tightening. The system uses Cynosure's patented MultiPlex technology to combine three wavelengths – 1064 nm, 1320 nm and 1440 nm – in one laser output. MultiPlex technology enables multiple wavelengths to be fired sequentially, creating a blended thermal and photomechanical effect that efficiently liquefies fat and tightens skin through tissue coagulation.
Cynosure plans to sell the products through its direct sales force in North America and Korea.
SmoothShapes XV and Smartlipo Triplex are also cleared for marketing in the United States by the U.S. Food and Drug Administration. Additionally, SmoothShapes XV is CE marked for sale in the European Union.
"SmoothShapes XV and Smartlipo Triplex are treatments that we believe deliver a superior outcome for the high-volume aesthetic applications they serve," said Michael Davin, president and chief executive officer of Cynosure. "The Cynosure brand is well established in Canada and Korea, and these clearances represent incremental growth opportunities. We are delighted to bring two of our newest workstations to these attractive markets."
Web Site: www.cynosurelaser.com