Medical device licence · 76334 · Class 3
HARMONY XL PRO
Yes: licensed in Canada
Licence status Issued (active); first licensed February 8, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76334
- Licence holder
- Alma Lasers Ltd.Nuernberg, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 8, 2008
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HARMONY XL SYSTEM - AFT COOLED HANDPIECE
- HARMONY XL SYSTEM - AFT HANDPIECE
- HARMONY XL SYSTEM - CONSOLE
- HARMONY XL SYSTEM - ER:YAG HANDPIECE
- HARMONY XL SYSTEM - ER:YAG HIGH POWER PIXEL HANDPIECE
- HARMONY XL SYSTEM - ER:YAG PIXEL HANDPIECE
- HARMONY XL SYSTEM - FOOTSWITCH
- HARMONY XL SYSTEM - LED HANDPIECE
- HARMONY XL SYSTEM - ND:YAG HANDPIECE
- HARMONY XL SYSTEM - NIR SHR HANDPIECE
- HARMONY XL SYSTEM - NIR SST HANDPIECE
- HARMONY XL SYSTEM - QS ND:YAG HANDPIECE
- HARMONY XL SYSTEM - REMOTE INTERLOCK CONNECTOR
- HARMONY XL SYSTEM - SYSTEM KEYSWITCH
- HARMONY XL SYSTEM - UVB HANDPIECE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.