Medical device licence · 112306 · Class 3
KARMA
Yes: licensed in Canada
Licence status Issued (active); first licensed November 29, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112306
- Licence holder
- El.En. S.P.A.Calenzano, FI, Italy
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 29, 2024
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1064NM ROUND BEAM SHAPER BLOCK
- 532NM ROUND BEAM SHAPER BLOCK
- KARMA
- MICROBEAM BEAM SHAPER BLOCK
- MICROBEAM SHAPE HANDPIECE BODY
- ROUND SHAPE HANDPIECE BODY
- ROUND SHAPE HANDPIECE BODY CARBON PEEL
- SQUARE BEAM SHAPER BLOCK
- SQUARE SHAPE HANDPIECE BODY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.