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).
Actual Zerona Photos
By Dr. Thomas Barnes
According to Dr. Thomas Barnes, an Orange County Zerona provder, the procedure works by shining a specific light wavelength at the treatment area. "There's 5 spinning lights, you don't feel a thing, it's non-invasive, and actually the fat cells in the body, under the influence of this specialized laser light that is low energy - there's no heat - it causes fat cells to leak some fat safely and if you do it every other day for 2 weeks, during that time you leak the fat and the body's lymphatic system pulls it away into the liver and it's metabolized, so it actually slims the body," says Dr. Barnes.
"Fat cells leave through a transitory pore that is developed under the influence of this particular non-invasive laser light. We lose an aggregate of 4 or 5 inches off of the hips, thighs and waist." Dr. Barnes points out that this is a non-invasive laser for what he calls "body slimming," in which inches are lost all over the body.
"If you're a busy business person and so forth, you don't have time to recuperate from surgery. It seems like it's ideal," says Dr. Robert Burke, a cosmetic surgeon and provider of Zerona in Ann Arbor, MI. Patients don't want to spend months waiting for final results and weeks, or even days recovering. In the current economy, for many missing work is simply not an option.
"The tape measure doesn't lie!" commented an elated female patient at VanderVeer Center, Portland's premiere cosmetic medicine facility, after completing the treatment for the ground-breaking non-invasive body slimming laser ZERONA. "I'm stunned," said VanderVeer Center patient Edie S. from the Portland area, "I lost 7 inches in two weeks. Unbelievable!"
Actual Zerona Results of Dr. Elizabeth VanderVeer
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."