Medical device licence · 105262 · Class 3
RENUVION ELECTROSURGICAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 9, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105262
- Licence holder
- Apyx Medical CorporationClearwater, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 9, 2020
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FOOTSWITCH BIPOLAR
- FOOTSWITCH MONOPOLAR
- RENUVION / J-PLASMA FOOTSWITCH DUAL PEDAL
- RENUVION / J-PLASMA HELIUM GAS REGULATOR
- RENUVION / J-PLASMA PRECISE HANDPIECE
- RENUVION / J-PLASMA PRECISE OPEN HANDPIECE
- RENUVION APR HANDPIECE
- RENUVION PRECISE HANDPIECE
- RENUVION SYSTEM GENERATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.