FDA grants 510(k) clearance for FX 635 laser device in chronic musculoskeletal pain

Erchonia Corp announced that the 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.

For comparison, the SPACE randomized clinical trial published in JAMA 2018 compared using opioids and non-opioids to treat overall chronic musculoskeletal pain. In the study, 119 patients were treated with opioids, and 119 patients were treated with non-opioids. At three months, results showed a reduction in pain of only 20% with opioids and 26% with non-opioids, mainly NSAIDS. This study also implemented many adjunctive therapies such as exercise, physical therapy and chiropractic care.

See: "Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial." Krebs EE et al. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/jama.2018.0899.