Search Menu
Photonics Media Photonics Buyers' Guide Photonics EDU Photonics Spectra BioPhotonics EuroPhotonics Industrial Photonics Photonics Showcase Photonics ProdSpec Photonics Handbook
More News
Email Facebook Twitter Google+ LinkedIn Comments

  • Lunula Laser Receives FDA Approval to Treat Nail Fungus
Jul 2016
MCKINNEY, Texas, July 21, 2016 — 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

Terms & Conditions Privacy Policy About Us Contact Us
back to top

Facebook Twitter Instagram LinkedIn YouTube RSS
©2016 Photonics Media
x We deliver – right to your inbox. Subscribe FREE to our newsletters.