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
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
CoreLink’s 3D Anterior Lumbar Approved by FDA
The implant allows for better imaging by minimizing material density.
Endo Resumes Lawsuit Against FDA Over Bulk Drug Compounding Decree
The company claimed the agency’s handling of bulk compounding laws violates the 2013 Drug Quality and Security Act, treating the laws as non-binding guidance rather than a legal mandate.
FDAnews Device Daily Bulletin
MERIDIAN ANNOUNCES 510K SUBMISSION TO THE FDA FOR THE LIPO-LASER
June 22, 2006