ApprovalTrail

Medical device licence · 78923 · Class 3

SMARTXIDE CO2 LASER SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 29, 2009. It is in Health Canada’s list of active licences.
Licence number
78923
Licence holder
Deka M.E.L.A. S.R.L.Calenzano, FI, Italy
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
January 29, 2009
Devices covered
3

Devices on this licence

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

  • SMARTXIDE CO2 LASER SYSTEM - DOT SCANNER
  • SMARTXIDE CO2 LASER SYSTEM - HANDPIECE SET
  • SMARTXIDE CO2 LASER SYSTEM - MAIN UNIT

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