BIOCARE SYSTEMS INFRARED THERAPY DEVICE GETS FDA CLEARANCE
BioCare Systems has received 510(k) clearance from the FDA to market its PremlR818 Infrared Therapy device for the relief musculoskeletal pain associated with arthritis, neck/back pain, joint sprains and muscle strains.
According to the company, infrared low-level light therapy (LLLT) stimulates natural biological processes in areas where the light is applied, promoting the body's natural healing and tissue immune responses. In clinical studies, LLLT has proven effective in relieving pain, reducing inflammation and increasing the speed, quality and tensile strength of tissue repair.
The PremlR818 device uses light emitting diodes in place of laser technology to deliver infrared light to patients, reducing the expense and potential hazards associated with the use of lasers to relieve pain. BioCare said the device should be available later this spring.