News
Erchonia Corporation (http://www.erchonia.com) , the world's leading
manufacturer in low-level laser technology, has been granted market
clearance by the U.S. Food and Drug Administration for the
non-invasive body contouring device, the Zerona. The Zerona is the
first non-invasive aesthetic device to receive FDA market clearance in
the U.S. for circumferential reduction of the waist, hips, and thighs.
The FDA granted market clearance following the completion of a
placebo-controlled, randomized, double-blind, multi-site clinical
investigation evaluating sixty-seven study participants. The results
obtained from that study demonstrated an average inch loss reduction
of 3.65 inches across patient's waist, hips, and thighs in as little
as two weeks. The clinical trial, absent of diet restrictions,
exercise requirements, or any other adjunctive components properly
illustrated the clinical utility of the Zerona and set the precedent
on how aesthetic devices should be evaluated.
FDA clearance for body contouring is just the latest clearance in a
long line for Erchonia's low-level laser devices having already earned
FDA market clearances for breast augmentation (2008), acne (2005),
liposuction (2004), and chronic pain (2001).
The Zerona emits a low-level
(http://www.erchonia.com/low-level-laser-therapy) , or cold, output
energy that generates no thermal effect on the body's tissue
eliminating any risk to the patient. Zerona has been clinically proven
to target fat cells causing their immediate collapse thereby
significantly reducing body volume. Through a natural process of fat
removal, the laser-released fat is safely removed and broken down,
providing patients with a truly non-invasive procedure without side
effects or downtime.
"Zerona (http://www.myzerona.com) is scientifically-proven to be both
safe and effective, and this most recent FDA clearance simply
validates the research supporting this application," says Charlie
Shanks, vice president of Erchonia. "Zerona's FDA clearance makes it
even more unique in the marketplace and we are excited to continue the
momentum with a new, integrated marketing campaign."
Having no predicate devices to base FDA clearance on, the Zerona had
to undergo a review process called de novo, which is completed by the
FDA in an average of 750 days. Erchonia submitted clinical data in
August 2008 and was granted approval for safety and effectiveness
nearly two years later.
About Erchonia Erchonia is the global leader in low level laser
healthcare applications. Over the last 15 years Erchonia has been
conducting research & development with the world's leading physicians
to advance the science of low level lasers. Prior to market
introduction, all Erchonia lasers are proven to be safe and effective
through independent clinical trials. Currently thousands of Erchonia's
lasers are used daily to reduce body fat, eliminate pain, accelerate
healing, and treat acne. For additional information, visit
www.erchonia.com (http://www.erchonia.com) .

