ApprovalTrail

Medical device licence · 84512 · Class 3

CO2RE SYSTEM (CO2 LASER)

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed November 22, 2010; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
84512
Licence holder
Candela CorporationWayland, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
November 22, 2010
Ended
December 9, 2025
Devices covered
5

Devices on this licence

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

  • CO2RE INTIMA EXTERNAL HANDPIECE STERILE SINGLE-USE
  • CO2RE INTIMA INTERNAL HANDPIECE STERILE SINGLE-USE
  • CO2RE SYSTEM - HANDPIECE
  • CO2RE SYSTEM - LENS
  • CO2RE SYSTEM - MAIN UNIT

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