FDA 510(k) MARKET CLEARANCE RECEIVED!

510 k approved 510 k approved

DECEMEBER 20, 2013

We are pleased to announce that the FDA has granted market clearance to the Luco Hybrid OSA appliance, the only appliance with a cast metal framework, for the treatment of mild to moderate obstructive sleep apnea and primary snoring in the USA!

The appliance is now market cleared and registered in Canada, the United States, the United Kingdom, Australia, and India!

510 k approved