The Zerona, a Low Level Laser Therapy (LLLT), 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. ZERONA has been featured on the The Doctors, CBS Early Show, Rachael Ray and many other national & local news segments.   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).

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 of nearly two years later.

The FDA also went so far as to describe the Zerona's mechanism of action as the "disruption of the adipocyte cells within the fat layer for the release of fat and lipids from these cells for non-invasive aesthetic use" and as a Class II device: "Low Level Laser System for Aesthetic Use."