FDAnews Device Daily Bulletin

MERIDIAN ANNOUNCES 510K SUBMISSION TO THE FDA FOR THE LIPO-LASER

June 22, 2006
A A

Meridian Co., Ltd. announced that it has reached a major milestone in the execution of its strategic business plan of establishing a significant role in the 9 billion dollar aesthetic market in North America. The company filed a Premarket Notification, or a 510(k) with the US FDA, to allow it to market the non-invasive Lipo-Laser device for the indication of body contouring and temporary reduction in the appearance of cellulite. Using cutting edge laser technology intended specifically for this use, this device will be the first of its kind that would be cleared by the US FDA.
Market Wire