MCKINNEY, Texas — The low-level Lunula Laser from Erchonia Corp. has received 510(k) approval from the U.S. FDA. Erchonia said it is the first low-level laser to receive marketing clearance for the treatment of onychomycosis, or nail fungus.
Toenails before and after receiving Lunula treatment. Courtesy of PRNewsFoto/Erchonia Corp.
In the product’s clinical trial, 67 percent of patients met the success criteria of 3 mm of clear nail growth. By six months after the initial treatment, these patients averaged more than 5 mm of new growth, Erchonia reported. The patients were between 18 and 70 years old, and received treatments once a week for four weeks.
The 510(k) is a premarketing submission to the FDA that demonstrates that the device marketed is safe and effective, and is the most rigorous type of device marketing application accepted by the FDA. Researchers at Erchonia cited no known side effects across four clinical studies of the device, which could avoids the toxicity potential of previous oral antifungal medical treatments.
Erchonia's FDA approved Lunula Laser. Courtesy of PRNewsFoto/Erchonia Corp.
For more information, visit www.erchonia.com.