The FDA clears the Luco Hybrid OSA Appliance as a Class 2 medical device for the treatment of mild to moderate obstructive sleep apnea and primary snoring. I has been assigned the 510(k) number 130797. It holds a second FDA clearance for treating sleep-related bruxism and to assist in treating associated tension and migraine headaches (510(k) number K160477). It is the only OSA appliance with two FDA clearances.
It should be noted that these approvals are only for patients 18 years of age or older. It should not be used on younger growing patients.
The Luco Hybrid is currently cleared for use in the USA through
.