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
The Luco Hybrid is now cleared for use in the following countries/regions:
CANADA
THE UNITED KINGDOM
THE EUROPEAN UNION
INDIA
AUSTRALIA.