Navigation Links
Erchonia Receives First-Ever FDA 510(K) Pain Indication Using a Violet Laser
Date:10/8/2019

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.

Read the full story at https://www.prweb.com/releases/erchonia_receives_first_ever_fda_510k_pain_indication_using_a_violet_laser/prweb16626933.htm.


'/>"/>
Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved


Related biology technology :

1. Erchonia Donates One Hundred and Fifty Thousand Dollars’ worth of Low-Level Lasers to the New York College of Podiatric Medicine & Foot Center of New York
2. Erchonia receives patent for noninvasive fat reduction.
3. EyeCRO Receives Full Accreditation from AAALAC International for its Research Facilities
4. Triangle Insights Group Receives Two Awards Recognizing Recent Growth
5. Singh Biotechnology Receives Second FDA Orphan Drug Designation for its Novel Single Domain Antibody for the Treatment of Osteosarcoma by Targeting Intracellular STAT3
6. Science Center’s FirstHand Program Receives National Award for Mentoring Initiatives
7. Circulomics Receives $1.7M to Develop Nanobind Methods for FFPE DNA/RNA Extraction and NGS Library Preparation
8. Bioarray Genetics Receives $4M in Series B Equity Financing
9. GeneOne Life Science Receives Approval for Phase I/IIa MERS-CoV Vaccine Trial in Korea
10. SFC Fluidics, Inc. Receives SBIR Phase II Funding for Development of an Implantable Drug Delivery Device
11. Heidelberg Instruments receives orders for advanced VPG+ Volume Pattern Generator from two Asian based photomask suppliers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2019)... , ... October 09, 2019 , ... ... Abernethy, MD, PhD, Principal Deputy Commissioner, FDA, as a newly-confirmed keynote speaker for ... 2019 in Las Vegas, Nevada USA. , Dr. Abernethy, a hematologist/oncologist and palliative ...
(Date:10/10/2019)... ... October 10, 2019 , ... R3 Stem Cell announces it has ... October 18-19th, 2019 in Las Vegas with spots still open. , The speaker, Dr. ... several Ivy League universities including Cornell, Harvard and Dartmouth. He currently serves as the ...
(Date:10/8/2019)... ... October 08, 2019 , ... ... Madhumita Suresh and Leslie Maurer presented company executives with a set of recommendations ... (MBS) graduates will offer insights from their TMP to a wider audience of ...
(Date:10/8/2019)... ... October 08, 2019 , ... Today, Massachusetts stem cell biotechnology company ... technology. Like the company’s precursor patent, approved in the U.S. in 2017, the ... stem cells. Asymmetrex now markets the technology in the U.S. as the AlphaSTEM ...
Breaking Biology Technology:
(Date:10/10/2019)... ... October 10, 2019 , ... ... ultrasound, invites attendees of the American Society of Anesthesiologists 2019 Annual Meeting to ... on October 19-21 in Orlando, Florida, and will provide more than 14,000 healthcare ...
(Date:10/8/2019)... (PRWEB) , ... October 07, 2019 , ... The future ... to the genetic level, resulting in people living longer, healthier lives. But it will ... on earth. , Leroy E. Hood, MD, PhD, Chief Strategy Officer and Co-Founder of ...
(Date:10/3/2019)... ... October 02, 2019 , ... Personalized Stem Cells, ... patient in an FDA approved clinical trial for stem cell treatment of knee ... formation of the company as a subsidiary of VetStem Biopharma. , PSC CEO, Michael ...
Breaking Biology News(10 mins):