This article was originally published in The Gray Sheet
Executive SummaryPlans to submit a premarket approval application to FDA within 90 days for its Microlight 830 nonsurgical cold laser for the treatment of repetitive stress injuries, including carpel tunnel syndrome. The Missouri City, Texas firm says that the device's 510(k) submission, submitted in September 1993, was deemed "not substantially equivalent" by the agency. The PMA will include data from a General Motors study involving 160 patients with chronic CTS. In addition, Lasermedics plans to submit a protocol to the agency by Feb. 1 to expand ongoing clinical trials for the Microlight to include additional conditions such as arthritis, wound healing and periodontal disease
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