Medical device licence · 86922 · Class 3
FOTONA DYNAMIS LASER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 15, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86922
- Licence holder
- Fotona D.O.O.Ljubljana, Slovenia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 15, 2011
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DYNAMIS MAX
- FOTONA ER: YAG SCANNER
- FOTONA G-RUNNER ADAPTORS
- FOTONA G-RUNNER HANDPIECE
- FOTONA ND: YAG SCANNER
- FOTONA SP DYNAMIS
- FOTONA XP DYNAMIS
- FOTONA XS DYNAMIS
- FRACTIONAL VARIABLE SPOT SIZE HANDPIECE
- 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.