ApprovalTrail

Medical device licence · 100602 · Class 2

STELLARIS ELITE VITRECTOMY PACK

Yes: licensed in Canada

Licence status Issued (active); first licensed February 16, 2018. It is in Health Canada’s list of active licences.
Licence number
100602
Licence holder
Bausch & Lomb Inc.Rochester, New York, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
February 16, 2018
Devices covered
13

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • STELLARIS ELITE 23 GA, BI-BLADE VIT CUTTER
  • STELLARIS ELITE 25 GA, BI-BLADE VIT CUTTER
  • STELLARIS ELITE 27 GA, BI-BLADE VIT CUTTER
  • STELLARIS ELITE PC 20 GA ANTERIOR VITRECTOMY
  • STELLARIS ELITE PC 23 GA ANTERIOR VITRECTOMY
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM BI-BLADE VITREOUS CUTTER COMBINED MID-FIELD STELLARIS ELITE PACK
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM BI-BLADE VITREOUS CUTTER COMBINED WIDE-FIELD STELLARIS ELITE PACK
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM BI-BLADE VITREOUS CUTTER POSTERIOR MID-FIELD STELLARIS ELITE PACK
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM BI-BLADE VITREOUS CUTTER POSTERIOR WIDE-FIELD STELLARIS ELITE PACK
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM COMBINED MID-FIELD ELITE PACK
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM COMBINED WIDE-FIELD ELITE PACK
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM POSTERIOR MID-FIELD ELITE PACK
  • STELLARIS ELITE VISION ENHANCEMENT SYSTEM POSTERIOR WIDE-FIELD ELITE PACK

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.