FDA Clears Erchonia’s Low Level Laser for Treating Musculoskeletal Pain

July 17, 2019

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.

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