ApprovalTrail

Medical device licence · 86845 · Class 2

FIBERLASE CO2 DELIVERY SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed August 8, 2011. It is in Health Canada’s list of active licences.
Licence number
86845
Licence holder
Lumenis Ltd.Salt Lake City, UT, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
August 8, 2011
Devices covered
5

Devices on this licence

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

  • FIBERLASE CO2 FIBER
  • FIBERLASE CO2 HAND PIECES
  • FIBERLASE ENDOSCOPE PROTECTION SHEATH
  • FIBERLASE ENDURE CO2 FIBER
  • FIBERLASE STC CO2 FIBER

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