Medical device licence · 71414 · Class 3
FOTONA XP MAX
Yes: licensed in Canada
Licence status Issued (active); first licensed May 23, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71414
- Licence holder
- Fotona D.O.O.Ljubljana, Slovenia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 23, 2006
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FOTONA XP MAX
- FOTONA XP MAX - HANDPIECE
- FOTONA XP MAX - S11 SCANNER
- ND:YAG VARIABLE SPOT HANDPIECE
- ND:YAG VARIABLE SPOT HANDPIECE WITH THERMAL DETECTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.