Medical device licence · 101516 · Class 4
VISUALASE MRI-GUIDED LASER ABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 27, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101516
- Licence holder
- Medtronic Navigation, Inc.Lafayette, CO, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- July 27, 2018
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VISUALASE COOLED LASER APPLICATOR SYSTEM
- VISUALASE NEURO ACCESSORY KIT
- VISUALASE PLATFORM
- VISUALIZATION STYLET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.