Successful 510(k) clearances including:

  • Refractory Glaucoma Implants
  • Photocoagulation Laser
  • Manual Instruments to lower IOP in glaucoma and for other indications
  • Dry Eye Therapeutics
  • Femtosecond lasers in cataract and refractive surgery
  • Ophthalmic lasers for other applications (glaucoma, retina, etc.)
  • Diagnostic imaging and measurement tools including tonometers and biometers
  • Collagen shields
  • Temperature regulation system for neurointensive care units
  • Aneurysm coils with novel configuration and polymer coating
  • Coil/clot removal device for intracerebral application