ApprovalTrail

Medical device licence · 112357 · Class 3

OPTIMASMAX

Yes: licensed in Canada

Licence status Issued (active); first licensed December 10, 2024. It is in Health Canada’s list of active licences.
Licence number
112357
Licence holder
Inmode Ltd.Yokneam, Israel
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
December 10, 2024
Devices covered
14

Devices on this licence

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

  • DIOLAZEXL MAX
  • FORMA
  • FUSION DARK
  • FUSION LIGHT
  • LUMECCA PEAK
  • MORPHEUS8 24 PIN
  • MORPHEUS8 40 PIN
  • MORPHEUS8 BURST
  • MORPHEUS8 BURST DEEP
  • MORPHEUS8 PRIME 12 PIN
  • MORPHEUS8 RESURFACING 24 PIN
  • OPTIMASMAX
  • PLUS
  • VASCULAZEMAX

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