Medical device licence · 108331 · Class 3
SIRIUS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 3, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108331
- Licence holder
- Candela CorporationWayland, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 3, 2022
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HR 600 APPLICATOR
- HRD 645 APPLICATOR
- HRL 600 APPLICATOR
- SIRIUS LASER SYSTEM
- VL 555 APPLICATOR
- VLS 555 APPLICATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.