Erchonia Receives First-Ever FDA 510(K) Pain Indication Using a Violet Laser
MELBOURNE, Fla., October 07, 2019 /PRNewswire-PRWeb/ -- Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT®"), today announces 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.
Erchonia continues to be the pioneer in developing new FDA indications for laser therapy; previously violet light has been solely for the use on dermatological conditions, i.e 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.
The treatment success for neck and shoulder pain is not new to Erchonia, as the company received the first FDA Market Clearance for laser therapy in 2002, based off (2) Level 1 blinded and controlled clinical studies using red laser only for the treatment of chronic neck and shoulder pain. (K012580)
About the EVRL Study: The purpose of this clinical study was to determine the effectiveness of the Erchonia® EVRL, 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 recording was recorded immediately after treatment using a 0 to 100 Visual Analog Pain Scale (VAS). The FDA predetermined the individual subject success as a 30% or greater decrease in pain. The EVRL Laser far exceeded criteria as ALL enrolled subjects experienced a reduction in pain following treatment, with the average pain reduction of 50%. Subjects also experienced an increase in range of motion (ROM) and subject satisfaction. Study results published in Medical Devices: Evidence and Research 2019:12 319-325.
"What makes the study results more impressive is the average duration of pain was 76.58 months. These subjects were living with chronic pain for an average of 6+ years, and with just a single treatment from the Erchonia EVRL Laser, they experienced a significant reduction in pain," comments Steven Shanks, President of Erchonia.
The study was pre-established as a non-inferiority study (equivalency or superiority) of the EVRL in red/violet diode combination therapy compared to the red diode only therapy as based upon the comparative data from the 2001 Erchonia clinical trial. Based off the results, the EVRL red/Violet combination outperformed the FDA Market Cleared red laser with respect to change in pain scores and improvement in shoulder range of motion.
"The addition of the violet light application with the red light has revolutionized my approach to treating musculoskeletal injuries. The lights synergy has increased my clinical outcomes substantially," comments Dr. Robert Silverman, D.C..
Erchonia would like to thank doctors Robert G Silverman and Albert Comey for their dedication to the science of low-level laser therapy and for helping document this clinical study.
About Erchonia Corporation
Based in Melbourne, Florida, family-owned Erchonia is the global leader in the manufacturing and development of low-level laser therapy technology ("3LT"). From humble beginnings in a garage in 1996, Erchonia today develops and sells the most advanced, non-invasive 3LT medical equipment on the market in over 50 countries. In fact, Erchonia first low-level laser market clearance in 2002 prompted the FDA to create a new device category: NHN Biostimulation lasers. With 17 different market clearances from the FDA, Erchonia remains passionately committed to effective, research-based 3LT solutions for a wide variety of conditions -- from managing chronic pain to promoting fat loss. For more information, please visit http://www.erchonia.com.
SOURCE Erchonia Corp.
