Erchonia has received 510(k) clearance from the US Food and Drug Administration for its low level laser technology to treat whole-body postoperative pain.
The company’s latest 510(k) statement from the U.S. FDA is based on level 1 blinded and controlled clinical trials.
The new FDA 510(k) statement for whole body treatment of postoperative pain was based on the company’s previously granted 510(k) statements from 2004 and 2008 along with data from seven randomized clinical trials on coronary artery bypass graft surgery, coronary bypass surgery with internal mammary artery grafts, tibial fracture surgery, cesarean section, endodontic surgery and tonsillectomy.
This FDA market clearance provides a drug-free and safe treatment option for postoperative pain, the company notes in a media release.
Based on clinical data, subjects who received Erchonia laser treatments experienced approximately 50% less pain and consumed fewer narcotics than the placebo group. The relief in subjects’ pain was reduced immediately after surgery and extended through 1 week, 2 week and 1 month postsurgery. Light-emitting diodes (LEDs) were used as a placebo device in each of the four measured time frames.
“The latest 510(k) statement once again proves Erchonia’s commitment to the science of low-level laser therapy through blinded and controlled clinical trials to obtain FDA 510(k) marketing statements. As the World Leader in Low Level Laser Technology, we have always believed we need to continue expanding the science of this amazing technology. This latest US FDA 510(k) statement adds to our commitment,” Travis Sammons, Erchonia’s Clinical Affairs Manager, states in the release.
[Source(s): Erchonia Corp, PRWeb]