Medical device licence · 110450 · Class 3
TIMEWALKER AT TIMEWALKER ST-E
Yes: licensed in Canada
Licence status Issued (active); first licensed November 23, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110450
- Licence holder
- Fotona D.O.O.Ljubljana, Slovenia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 23, 2023
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ER:YAG FRACTIONAL OPTICAL HANDPIECE
- ER:YAG OPTICAL HANDPIECE
- G-RUNNER
- HANDPIECE
- ND: YAG SURGICAL HANDPIECE
- ND:YAG AND DIODE OPTICAL HANDPIECE
- ND:YAG OPTICAL HANDPIECE
- OPTICAL HANDPIECE
- TIMEWALKER AT
- TIMEWALKER ST-E
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.