Medical device licence · 83113 · Class 3
HARMONY SHR SYSTEM - MULTI-APPLICATION, MULTI-TECHNOLOGY PLATFORM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83113
- Licence holder
- Alma Lasers Ltd.Nuernberg, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 22, 2010
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HARMONY LITE SYSTEM
- HARMONY SHR SYSTEM - MODULE S-ACNE
- HARMONY SHR SYSTEM - MODULE SHR COOLED
- HARMONY SHR SYSTEM - MODULE SSR COOLED
- HARMONY SHR SYSTEM - MODULE SST COOLED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.