A new technology known as Zerona®, a ‘cold’ laser, has been granted market clearance by the FDA for “use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.”

This clearance followed the completion of a placebo-controlled, randomized, double blind, and multi-site clinical investigation evaluating 72 study participants. According to www.clinicaltrials.gov, the results obtained from that study demonstrated a reduction of at least three inches off their combined waist-hips-thighs circumference in as little as two weeks.  

The clinical effectiveness of Zerona body contouring cold laser, which is completely non-invasive, non-surgical, painless and without known side effects, was demonstrated without the need for adjunctive components such as diet restrictions or exercise requirements, although these are strongly recommended.

Zerona produces low-level, or cold, output energy that does not thermally damage the body areas treated, making the therapy completely safe, comfortable and without “downtime” for recovery.

The targeted superficial fat cells develop a small “pore” through which the stored fat is extruded into the space in between the cells known as the “interstitial space.”  

This fat, through natural body processes, is then collected by lymphatics and transferred to the blood stream and ultimately to the liver for elimination. The fat cells treated are seen by electron microscopy to collapse and resemble a “crushed grape.”

Zerona’s scientific clearance by the FDA was unique and set a precedent for how aesthetic devices should be reviewed, as it required FDA to create a new category. Under these circumstances, the FDA required the Zerona to pass a specific review process, de novo, which is completed by the FDA in an average of 750 days.  

Erchonia, the manufacturer of Zerona, submitted clinical data in August 2008 and was granted market clearance for safety and effectiveness nearly two years later.

It is only indicated for superficial fat between the body surface and the muscle level below it. It does not treat the deep visceral fat found around organs such as the liver and kidney. So it is not a treatment for weight loss, diabetes or other medical conditions associated with deep fat stores.

“FDA approval means the data collection is only beginning; we don’t really know how effective [this procedure] will be in clinical practice,” says plastic surgeon Felmont Eaves, MD, president of the American Society for Aesthetic Plastic Surgery. “This device certainly is not as aggressive as liposuction and is really meant for small, isolated areas.”

Zerona is designed for body slimming, sculpting, or trimming. People who have “pouchy tummys,” “love handles” and “muffin tops” around their abdomen, thighs or buttocks are the groups likely to benefit the most.

Treatments are very simple and require at least six treatments of 40 minutes per treatment every other day for two weeks. Some people will require 9-12 treatments.