www.fdanews.com/articles/205206-erchonia-pain-treating-laser-device-gets-fdas-510k-clearance
Erchonia Pain-Treating Laser Device Gets FDA’s 510(k) Clearance
November 5, 2021
Melbourne, Fla.-based Erchonia has received 510(k) marketing clearance from the FDA for its laser treatment device for postoperative pain.
Participants in a clinical study who received the Erchonia low-energy laser treatments after surgery experienced approximately 50 percent less pain and consumed fewer narcotics than those in a placebo group.
The subjects experienced reduced pain levels immediately after surgery, and the relief continued at the one-week, two-week and one-month mark after their operations, the company said.