The Luco Hybrid OSA Appliance is FDA Approved

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

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The Luco Hybrid is now cleared for use in the following countries/regions:

      USA

                

     CANADA

 

     THE UNITED KINGDOM 

 

   THE EUROPEAN UNION

 

   INDIA   

    

    AUSTRALIA.