Medical device licence · 94931 · Class 3
PICOWAY LASER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 26, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94931
- Licence holder
- Candela CorporationWayland, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 26, 2015
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASSY PICO ZOOM HIP
- PICOWAY HANDPIECE AND DISTANCE GAUGES
- PICOWAY HANDPIECE, RESOLVE HANDPIECE, AND RESOLVE DISTANCE GAUGES
- PICOWAY HIGH ENERGY AND RESOLVE HANDPIECES, DISTANCE GAUGES
- PICOWAY HIGH ENERGY RESOLVE HANDPIECE AND RESOLVE DISTANCE GAUGES
- PICOWAY LASER SYSTEM
- PICOWAY RESOLVE FUSION HANDPIECE
- PICOWAY RESOLVE HANDPIECE AND RESOLVE DISTANCE GAUGES
- REFURBISHED PICOWAY 1064 RESOLVE HANDPIECE ASSEMBLY
- REFURBISHED PICOWAY 730 HANDPIECE ASSEMBLY
- REFURBISHED PICOWAY 785 HANDPIECE ASSEMBLY
- REFURBISHED PICOWAY ZOOM HANDPIECE ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.