Indications For Use By Region

The Luco Hybrid OSA Appliance Is Registered With:

Health Canada MDEL 5315

  • sleep apnea in adults
  • snoring in adults
  • sleep bruxism in adults

FDA  K130797

  • sleep apnea in  adults
  • snoring in adults

FDA K160477

  • the treatment of sleep bruxism
  • aid in the treatment of associated tension/migraine type headaches in adults

European Union MHRA

  • sleep apnea in adults
  • snoring in adults
  • sleep bruxism in adults

Australia 201620244

  • sleep apnea in adults
  • snoring in adults
  • sleep bruxism in adults

 

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