Device Dossier
Ophthalmic fibreoptic-light instrument, single-use
Device Dossier for Ophthalmic fibreoptic-light instrument, single-use (Ophthalmic fibreoptic-light instrument, single-use, Class IIa, sponsor Bausch &…
- GMDN category: Ophthalmic fibreoptic-light instrument, single-use
- Sponsor: Bausch & Lomb
Intended purpose
The intended use of this device is for the provision of light for tissue manipulation, irrigation/aspiration and coagulation during ophthalmic surgery. The device is to be used in a controlled surgical environment on Millennium, Stellaris or Stellaris PC Microsurgical systems. Light pipes are supplied sterile and intended for single-use.