The US Food and Drug Administration (FDA) has granted marketing clearance to the Erchonia Corporation for its FX 635 low-level laser as treatment for “whole body” musculoskeletal pain, the manufacturer has announced.
The 510(k) clearance will allow the marketing of the device to provide temporary relief from pain that is chronic and nociceptive in adult patients.
The decision was based in part on a randomized, placebo-controlled trial of more than 200 patients with this type of pain. Results showed that those who received the laser therapy without any adjunctive treatment had a 49% reduction in pain post-treatment.
This is greater than the results from the large SPACE trial, published in JAMA in 2018. That trial showed a pain-reduction rate of 20% for opioids and 26% for non-opioids, which were mainly NSAIDs, the manufacturer notes.
Charlie Shanks, vice president at Erchonia, noted in a press release that previous FDA clearances the company has received for its therapeutic laser technology were limited to specific areas of the body.
Now, the company has “the only whole-body indication based on Level 1 clinical data,” he said in a press release.
“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” by clinicians treating these patients, Shanks added.
On its website, under the subcategory “Lasers for Pain,” Erchonia notes that the FX 635 was previously cleared by the FDA to treat heel pain associated with plantar fasciitis and chronic low back pain.
For the latter indication, the device uses “low-level laser technology and patented laser diode arms to precisely target lower back pain centers. It reduces inflammation while promoting biostimulation at a cellular level in the musculoskeletal point of the pain’s origination,” the manufacturer writes.
It notes that today’s market clearance was based on the earlier mentioned trial in patients with chronic musculoskeletal pain, as well as on previous trials of patients with chronic neck and shoulder pain (conducted in 2002), 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,” they add.