Search Menu
Photonics Media Photonics Marketplace Photonics Spectra BioPhotonics EuroPhotonics Vision Spectra Photonics Showcase Photonics ProdSpec Photonics Handbook

Lunula Laser Receives FDA Approval to Treat Nail Fungus

Facebook Twitter LinkedIn Email Comments
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

Sep 2016
BusinessAmericascommercializationFDATexaserchonialunulalasersBiophotonicsfungusclinical trialmedicalantifungalRapidScan

back to top
Facebook Twitter Instagram LinkedIn YouTube RSS
©2021 Photonics Media, 100 West St., Pittsfield, MA, 01201 USA, [email protected]

Photonics Media, Laurin Publishing
x Subscribe to BioPhotonics magazine - FREE!
We use cookies to improve user experience and analyze our website traffic as stated in our Privacy Policy. By using this website, you agree to the use of cookies unless you have disabled them.