ApprovalTrail

Medical device licence · 112966 · Class 3

THERMAGE FLX SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed March 27, 2025. It is in Health Canada’s list of active licences.
Licence number
112966
Licence holder
Solta Medical Inc.Bothell, WA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 27, 2025
Devices covered
7

Devices on this licence

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

  • REPLACEMENT FLX HANDPIECE
  • THERMAGE FLX BODY TIP
  • THERMAGE FLX CANADA, REFURBISHED
  • THERMAGE FLX EYE TIP
  • THERMAGE FLX TOTAL TIP
  • THERMAGE HANDPIECE
  • THERMAGE RF GENERATOR

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