FDA clears MedX's Oralase laser pain-treatment device
OCTOBER 7, 2008 -- The US Food and Drug Administration (FDA) has cleared MedX Health's (Mississauga, Canada) Oralase Portable Laser for marketing. Oralase, a low level laser therapy (LLLT) device, is designed to alleviate pain and accelerate tissue repair following dentistry procedures. The device also promises to relieve pain and accelerate healing in cosmetic surgery and skin treatments.
OCTOBER 7, 2008 -- MedX Health Corp. (Mississauga, ON, Canada), says its Oralase Portable Laser has been cleared for marketing by the Food and Drug Administration (FDA). MedX's distribution partner, laser company Technology4Medicine (San Clemente, CA) will begin immediate distribution to dental offices in the United States. Oralase is a photobiomodulation device, also known as low level laser therapy (LLLT), designed for dentists to alleviate pain and accelerate tissue repair following dental procedures.
The non-invasive, drug-free solution promises to provide pain relief due to oral surgery and other dental treatments -- plus non-dentistry markets such as dermatology and plastic surgery. "Oralase will not only relieve the pain by accelerating tissue repair, but it will provide patients the increased comfort of accelerated healing," said Steve Guillen B.Sc., M.B.A., president and chief executive officer, MedX Health.
For more than 35 years, LLLT has been used in Europe, Australia, Asia and Russia for the treatment of pain and tissue repair. MedX's LLLT was approved in Canada in 1999 and in the United States in 2002. LLLT uses a specific type of light to penetrate the skin's surface and underlying tissues to stimulate the body's natural repair processes. The result is faster healing and reduced pain, swelling and inflammation. The technology has advanced laser therapy significantly, and according to MedX, Oralase embodies the new generation of photobiomodulation technology for health care today.