Erchonia Corporation announces that the US Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its FX 635 low-level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.
Erchonia received FDA clearance after submitting results from double-blind and placebo-controlled clinical trials with 255 patients. Those treated with the FX 635 documented a 49% average pain reduction post treatment protocol. No other therapies were used in conjunction with the laser treatment.
“While our previous clearances from the FDA have already set us apart from the rest of the therapeutic laser industry, until now, they have all been limited to specific areas of the body,” comments Charlie Shanks, VP of Melbourne, Vla-based Erchonia, in a media release. “Now Erchonia has the only whole-body indication based on Level 1 clinical data.”
Although this new 510(k) is not limited to one specific area of the body, market clearance was also based on Erchonia’s previous Level 1 blinded and controlled clinical trials on chronic neck and shoulder pain in 2002; plantar fasciitis, or heel pain, in 2014; and low back pain in 2018.
Erchonia’s other 510(k) market clearances for post-surgical pain in 2004 and 2008 were not part of this FDA submission as they were acute pain studies, not chronic pain, the company notes.
For more information, visit Erchonia Corporation.
[Source(s): Erchonia Corporation, PR Newswire]