HUD / HDE Submissions

Orphan device designations and approvals, including:

  • Corneal Therapeutic Devices
  • Intraocular Lenses
  • Intracerebral stent for stroke prevention
  • Intrabronchial valves for pulmonary indication

De Novo Petitions

Successful Class II De novo petitions, including:

  • Smart Contact Lens
  • Neurostimulation for Dry Eye Disease