WOODMERE, N.Y.--()--Nomir Medical Technologies, Inc., a leader in novel photobiology and laser therapies, announced today that the company has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the indication of temporary increase of clear nail in patients with onychomycosis (toenail fungus).
“We are committed to scientifically demonstrating the safety and efficacy of the Noveon Podiatric Laser using all of the data from our clinical trials”
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 (JAPMA). This paper (JAPMA 102(2): 169-171, 2012), containing 270 day follow-up clinical data from a pivotal trial, is the third in a series of articles published in the peer-reviewed JAPMA about the Noveon Podiatric Laser.
“We are committed to scientifically demonstrating the safety and efficacy of the Noveon Podiatric Laser using all of the data from our clinical trials,” said Dr. Eric Bornstein, Founder and Chief Scientific Officer of Nomir Medical.
Disclaimer: The Noveon Laser has not been cleared by the FDA for the treatment of onychomycosis.
The Noveon delivers continuous wave laser light in the contact or non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of soft tissue.
About Noveon Laser
The Noveon™ Laser is a medical device intended to treat podiatric and dermatological conditions. The Noveon Laser is fully automatic, freeing clinicians from manual lasing procedures. The Noveon Laser is backed by several US and foreign patents, and is CE Mark certified to meet or exceed global engineering standards. For more information, please visit NoveonLaser.com.
About Nomir Medical Technologies, Inc.
Nomir Medical Technologies, Inc. is a medical device company that develops therapies to treat diseases that afflict millions of people worldwide. The company’s products are designed to meet the needs of patients and physicians based on patented laser technologies that have been rigorously tested in lab and clinical trials since 2001. For more information, please visit NomirMedical.com.