Nomir Medical Submits 510(k) Application to FDA for Onychomycosis
09/11/2012
Nomir Medical Technologies, Inc. submitted a 510(k) application to the US Food and Drug Administration (FDA) for the indication of temporary increase of clear nail in patients with onychomycosis (toenail fungus). This 510(k) submission to FDA for the Noveon Podiatric Laser contains additional data from its pivotal onychomycosis trial first published in the Journal of the American Podiatric Medical Association (102(2):169-171). Disclaimer: The Noveon Laser has not been cleared by the FDA for the treatment of onychomycosis.