U.S Food and Drug Administration conceded to Multi Radiance Medical‘s MR4 Laser technology for neck and shoulder pain relief under the Product Classification NHN. MR4 Laser technology sought the NHN product class FDA 510(K) clearance.
Multi Radiance CEO Max Kanarsky said “is the very rigorous and expensive process, which includes conducting and submitting data to support the claims of safety and effectiveness.”
Statistics reveal that around 35 million adults in the U.S. suffer from neck pain and neck pain is second only to low back pain in annual workers’ compensation costs in the United States. 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.
Douglas Johnson, Senior VP, Clinical and Scientific Affairs said “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.”