The Luco Hybrid OSA Appliance has been cleared by the FDA as a Class 2 medical device for use in the United States for the treatment of mild to moderate obstructive sleep apnea and primary snoring and assigned the 510(k) number 130797. It holds a second FDA clearance for the treatment of sleep- related bruxism and to assist in the treatment of associated tension and migraine headaches. It is the only OSA appliance with two FDA clearances.
The Luco Hybrid is now cleared for use in the following countries/regions:
THE UNITED KINGDOM
THE EUROPEAN UNION