The FDA 510(k) clearance has been granted based on its premarket notification for indications for the use of elevating tissue temperature and temporary relief of muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and temporary relaxation of muscle, the company said.
According to the company, the FDA clearance allows it to market the Lapex body contouring system (BCS) which is a safe and pain free, non-invasive laser device.