The US Food and Drug Administration has cleared Multi Radiance Medical’s MR4 Laser technology for neck and shoulder pain relief under the product classification NHN, indicating a non-thermal device.
Reportedly, only a limited number of therapeutic laser technologies sold in the United States have received 510(k) clearance under the NHN designation.
“The reason for this,” states Multi Radiance CEO Max Kanarsky, in a media release, “is the very rigorous and expensive process, which includes conducting and submitting data to support the claims of safety and effectiveness.”
The FDA clearance was granted as the result of a randomized, double blind, controlled study suggesting that Multi Radiance MR4 Laser technology is more effective than placebo for reducing neck and shoulder pain.
“Globally, Multi Radiance Medical participates currently in over 30 clinical trials and has published a dozen peer reviewed articles in the last two years,” adds Douglas Johnson, Senior VP, Clinical and Scientific Affairs, in the release. “We want to congratulate our regulatory team, Dr Ernesto Leal, Jr, and our research team at the Laboratory of Phototherapy in Sports and Exercise on this remarkable achievement.”
[Source(s): Multi Radiance Medical, Business Wire]