Zerona and FDA

FDA Clearance Drives ZERONA Demand and Interest On August 24th ZERONA was granted FDA market clearance as the first non-invasive aesthetic device to receive FDA market clearance in the U.S. for circumferential reduction of the waist, hips and thighs!

Click here for entire FDA release.

ZERONA’s FDA market clearance is particularly noteworthy because:

• The FDA has cleared ZERONA as both safe and effective for use in circumferential reduction of the hips, waist, and thighs.
• A new category for ZERONA - As the first device of its kind, ZERONA had to undergo a more stringent review process with the FDA called de novo, which is completed by the FDA in an average of 750 days. The clinical data was submitted to the FDA in August 2008 (Click Here to review clinical study)

ZERONA’s ground-breaking FDA clearance has captured the attention of national and regional media - click here to view

ZERONA® is the first non-invasive body contouring procedure
to effectively remove excess fat.