HOUSTON, Feb. 12 -- MicroLight Corp. of America said it has won market clearance from the Food and Drug Administration for its ML830 Cold Laser for use in the nonsurgical treatment and management of carpal tunnel syndrome (CTS).
"FDA market clearance for the ML830 resulted from working with FDA examiners over the past ten years to ensure continuing compliance with the law," said Mike Barbour, MicroLight president. "Our ML830 successfully performed in several double-blind studies and in many clinical trials where some rather substantial parties were involved, including Baylor College of Medicine and General Motors," he added.