Medical device licence · 79689 · Class 3
ULTHERA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 6, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79689
- Licence holder
- Ulthera, Inc.Raleigh, NC, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 6, 2009
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRIME UPGRADE KIT
- ULTHERA AESTHETIC ULTRASOUND SYSTEM - CONTROL UNIT
- ULTHERA AESTHETIC ULTRASOUND SYSTEM - DEEPSEE HANDPIECE
- ULTHERA AESTHETIC ULTRASOUND SYSTEM - DEEPSEE TRANSDUCER
- ULTHERA AESTHETIC ULTRASOUND SYSTEM - USER ACCESS KEY
- WIFI ADAPTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.