MedX Health, a provider of drug free, non-invasive therapeutics for tissue repair and pain relief, has announced that its Oralase portable laser has received 510(k) clearance from the FDA.
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MedX’s distribution partner, Technology4Medicine, a laser company in San Clemente, California will begin immediate distribution of Oralase to dental offices in the US.
Oralase is a photobiomodulation device, also known as low level laser therapy, exclusively designed for dentists to alleviate pain and accelerate tissue repair following dental procedures.
Steve Guillen, president and CEO of MedX Health, said: “We are very pleased to have received the 510(k) clearance letter from the FDA so that we can begin to immediately provide the dental community with our non-invasive and drug free solution to relieve pain due to surgical and other procedures.
“Through our partnership with Technology4Medicine, we expect to fulfill a great unmet need in the dental community as well as other markets including dermatology and plastic surgery.”
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