SOLON, Ohio--(BUSINESS WIRE)--After extensive review and evaluation, the U.S. Food and Drug Administration (FDA) recently cleared Multi Radiance Medical’s MR4 Laser technology for neck and shoulder pain relief under the Product Classification NHN, making Multi Radiance one of the few laser manufacturers in the world to secure the NHN product class FDA 510(k) clearance.
While many therapeutic laser companies sell products in the United States, only a limited number have received clearance under the NHN designation, indicating a non-thermal device.
“The reason for this,” states Multi Radiance CEO Max Kanarsky, “is the very rigorous and expensive process, which includes conducting and submitting data to support the claims of safety and effectiveness.”
The results of the randomized, double blind, controlled study submitted show that Multi Radiance MR4 Laser technology is more effective than placebo for reducing neck and shoulder pain.
Statistics reveal that around 35 million adults in the U.S. suffer from neck pain1, and neck pain is second only to low back pain in annual workers’ compensation costs in the United States2. The new NHN classification gives clinicians and patients a clinically proven safe and effective alternative to opioids and other drugs for managing this common pain.
This is the latest visible step in Multi Radiance’s quest to become the dominant market leader in laser therapy.
“Globally, Multi Radiance Medical participates currently in over 30 clinical trials and has published a dozen peer reviewed articles in the last two years,” added Douglas Johnson, Senior VP, Clinical and Scientific Affairs. “We want to congratulate our regulatory team, Dr. Ernesto Leal Junior, and our research team at the Laboratory of Phototherapy in Sports and Exercise on this remarkable achievement.”
About Multi Radiance Medical
Multi Radiance Medical is a leading medical device company that develops and manufactures FDA-cleared laser equipment using super pulsed laser technology, for the temporary relief of acute/chronic pain, muscle stiffness, arthritis, muscle spasms, chronic neck and shoulder pain of musculoskeletal origin, and other conditions. Its LaserStim™ with TARGET technology is the first FDA-cleared device to combine laser light and electrical stimulation. Multi Radiance Medical has served rehabilitation, chiropractic, physiatry, sports medicine and veterinary markets for 20 years and is in more than 30 countries.
1. Center for Disease Control and Prevention (CDC). (2015). Severe headache or migraine, low back pain, and neck pain among adults aged 18 and over, by selected characteristics: United States, selected years 1997–2014. Retrieved from https://www.cdc.gov/nchs/data/hus/2015/041.pdf
2. Wright, A., Mayer, T. G., & Gatchel, R. J. (1999). Outcomes of disabling cervical spine disorders in compensation injuries: a prospective comparison to tertiary rehabilitation response for chronic lumbar spinal disorders. Spine, 24(2), 178-183.