FDA Approves Zerona Body Sculpting as Safe and Effective

Zerona®, a non-invasive body slimming procedure, is now FDA approved for both safety and efficacy in achieving superficial fat dissolving. Zerona® is a clinically proven alternative to liposuction in losing fat and inches. ZERONA®, the safest and most researched low-level laser in the world, allows physicians to help patients enjoy better health and well-being.

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.

How it Works

Zerona produces low-level, or cold, output energy that does not thermally damage the body areas treated, making Zerona therapy completely safe, comfortable and without downtime for recovery. Zerona targets superficial fat cells which develop a small pore, through which the stored fat is extruded into the space in between the cells know as the interstitial space. This fat, through natural body processes, is then collected by lymphatics and transferred to the blood stream and ultimately transferred to the liver for elimination. The fat cells treated by Zerona are seen by electron microscopy to have collapse and resemble a crushed grape.

During the Zerona treatment, normal fat cells begin to shrink and leak their contents. After prolonged laser exposure the fat cells completely collapse.

FDA Approval Process

Zerona’s scientific clearance by the FDA was unique and set a precedent for how aesthetic devices should be reviewed. Since there exists no similar technology which has been previously FDA evaluated, the FDA required the Zerona to pass a specific review process, the so-called 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 approval for safety and effectiveness nearly two years later.

A Highly Effective Alternative to Liposuction

Zerona is great 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. Frustrated, many people, having failed diet and exercise to resolve their aesthetic body fat problems, had no other choice but to turn to the very expensive and invasive liposuction procedures.

Zerona 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.

Zerona Treatments

Zerona will now provide people with a very feasible, less expensive and effective alternative to body sculpting. Zerona treatments are very simple and require at least 6 treatments of 40 minutes per treatment every other day for two weeks. Some people will require 9-12 treatments.