Erchonia Receives First-Ever FDA 510(k) Pain Indication Using a Violet Laser

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Erchonia Corporation announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) market clearance to market its EVRL low-level laser for the temporary relief of chronic neck and shoulder pain of musculoskeletal origin. Previously, violet light has only been used on dermatological conditions, such as acne. With this new indication, the EVRL becomes that first and only violet laser (405nm) to receive FDA market clearance for the use on an indication related to pain.

EVRL
Courtesy of Erchonia


In a study published in Medical Devices: Evidence and Research, the effectiveness of the Erchonia EVRL was evaluated, when both the red and violet diodes are activated simultaneously. The lasers were active for 13 minutes and no other therapies were used in conjunction. The subject's pain level was recorded immediately after treatment. The FDA predetermined the individual subject success as a 30 percent or greater decrease in pain. All enrolled subjects experienced a reduction in pain following treatment, with the average pain reduction of 50 percent. Subjects also experienced an increase in range of motion (ROM) and subject satisfaction.

"What makes the study results more impressive is the average duration of pain was 76.58 months," says Steven Shanks, president of Erchonia. "These subjects were living with chronic pain for an average of 6-plus years, and with just a single treatment from the Erchonia EVRL laser, they experienced a significant reduction in pain."


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