The approval of FX 635 low level laser was based on data from double-blind and placebo-controlled clinical trials with 255 patients.
According to the company, the patients treated with the FX 635 showed a 49% average pain reduction post treatment protocol and no other therapies were used in conjunction with the laser treatment.
The FDA approval was also based on the firm’s earlier 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 said its 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 SPACE randomised clinical study compared the use of opioids and non-opioids for the treatment of overall chronic musculoskeletal pain.
In the study, 119 patients have been treated with opioids and other 119 patients were treated with non-opioids.
The results demonstrated a reduction in pain of only 20% with opioids and 26% with non-opioids mainly NSAIDS, at three months.
In addition, the study implemented multiple adjunctive therapies such as exercise, physical therapy and chiropractic care.
Erchonia vice president Charlie Shanks said: “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.
“Now Erchonia has the only whole-body indication based on Level 1 clinical data. Based on these results, the fact that there are no known negative side effects, and that it’s non-addictive, our low-level laser technology should be considered first.
“It’s more effective than opioids or NSAIDS when treating chronic musculoskeletal pain when you compare the SPACE study results with those Erchonia submitted to the FDA.”
Based in Melbourne of Florida, Erchonia is involved in the manufacturing and development of low level laser therapy technology (3LT). – NS Medical Devices