MCKINNEY, Texas--(BUSINESS WIRE)--Erchonia today announces the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance to market Erchonia’s Zerona body-contouring laser treatment for the non-invasive reduction of arm circumference based on a level 1 blinded and controlled clinical trial.
“The arms have always been a difficult area to treat through diet, exercise or even surgery,” says Steven Shanks, president of Erchonia. “But in just 2 weeks of treatments with the Zerona laser, Erchonia’s study proved patients could lose approximately 4 cm off of their arms without diet, exercise or nutritional supplementation. Patients treated with a placebo laser did not show any significant changes in arm reduction.”
The upper arms are unique in that no other confounding factors such as diet that can affect the circumference, especially over a relatively short period of time. The results of the study showed a highly statistically significant difference in circumference reduction, which was still present at least 7.6 months after treatment, between the Zerona treated vs the sham treated patients. It also revealed a very high degree of patient satisfaction in the Zerona treatment group.
Dr. Mark Nestor, the lead investigator for the study, adds, “After seeing firsthand the results of the Zerona noninvasive body sculpting device on patients’ waists, hips and thighs, I wanted to assess the efficacy of the low-level laser on the upper arms in a rigorous level 1, double blind, multicenter, sham-controlled study. The study shows Zerona’s low-level laser therapy is effective in reducing upper arm circumference without any pain or side effects.”
This is the second FDA 510k market clearance Erchonia has secured for its Zerona technology. In August 2010, after submitting its level 1 clinical data, Erchonia became the first and only device with 510k market clearance from the FDA for the circumference reduction of the waist, hips and thighs not to mention the first non-invasive device of any kind given a 510k market clearance from the FDA for fat reduction. Erchonia is also the first and only laser company given a 510k market clearance for liposuction which was based on its level 1 clinical trial in 2004. Erchonia has been researching the effect of its low level lasers on fat cells since 1998, and peer reviewed journals have been publishing its research since 2001.
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven 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.