ApprovalTrail

Medical device licence · 115288 · Class 3

GME FLEXSYS

Yes: licensed in Canada

Licence status Issued (active); first licensed April 29, 2026. It is in Health Canada’s list of active licences.
Licence number
115288
Licence holder
Luvo Medical Technologies, Inc.Cambridge, Ontario, Canada
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
April 29, 2026
Devices covered
8

Devices on this licence

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

  • FLEXSTS BASE UNIT
  • FOOTSWITCH
  • HANDPIECE FOR 532NM & 577NM MODULES
  • SCANNER FOR 1550NM MODULE
  • SCANNER FOR 532NM MODULE
  • SCANNER FOR 577NM MODULE
  • UVB EPL 308
  • UVB EPL LITE 308

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