The FDA has granted Erchonia 510(k) clearance for its FX-635 laser system for the temporary treatment of musculoskeletal pain caused by physical injury.
The system uses controlled, low-level laser technology and diode arms to precisely target areas of pain in the patient’s lower back. It eliminates the need for opioids and nonsteroidal anti-inflammatory drugs. The system is non-invasiveness and has a shorter recuperation period.
Double-blind and placebo-controlled clinical trials showed a 49 percent average pain reduction after treatment without any other therapies.