Medical device licence · 75829 · Class 3
FRAXEL RE:FINE LASER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 10, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 75829
- Licence holder
- Solta Medical Inc.Bothell, WA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 10, 2007
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FRAXEL RE:FINE LASER SYSTEM - DISINFECTION KIT
- FRAXEL RE:FINE LASER SYSTEM - MAIN UNIT
- FRAXEL RE:FINE LASER SYSTEM - SINGLE TIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.