Medical device licence · 105228 · Class 3
SKYPULSE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 9, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105228
- Licence holder
- Fotona D.O.O.Ljubljana, Slovenia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 9, 2020
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIODE OPTICAL HANDPIECE
- ER:YAG OPTICAL HANDPIECE
- FIBER TIP
- LASER MODULE
- SKYPULSE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.