Medical device licence · 102519 · Class 3
VBEAM PRIMA
Yes: licensed in Canada
Licence status Issued (active); first licensed March 7, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102519
- Licence holder
- Candela CorporationWayland, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 7, 2019
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASSY, DELIVERY SYS, DCD, HP, PRIMA REFURBISHED
- DCD DELIVERY HANDPIECE
- EVERCOOL DELIVERY HANDPIECE
- FOOTSWITCH
- MEGADYE CARTRIDGE
- VBEAM PRIMA
- VBEAM PRIMA DCD DELIVERY SYSTEM
- VBEAM PRIMA PRO LASER SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.