Medical device licence · 111096 · Class 3
ULTRAPULSE ALPHA
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111096
- Licence holder
- Lumenis Be Ltd.Yokneam, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 18, 2024
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DEEPFX MICROSCANNER
- FEMTOUCH FINE FOCUS DISPOSABLE TIP
- FEMTOUCH FINE FOCUS TIP KIT
- FEMTOUCH FINE PANORAMIC DISPOSABLE TIP
- FEMTOUCH FINE PANORAMIC TIP KIT
- FEMTOUCH STANDARD FOCUS TIP
- FEMTOUCH STANDARD PANORAMIC TIP KIT
- FEMTOUCH STD. FOCUS DISPOSABLE TIP
- FEMTOUCH STD. PANORAMIC DISPOSABLE TIP
- FOCUSED INCISIONAL HANDPIECE SET
- TRUESPOT 2.0 MM HANDPIECE
- ULTRAPULSE ALPHA
- ULTRASCAN CPG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.