Medical device licence · 110910 · Class 3
APYX -ONE CONSOLE
Yes: licensed in Canada
Licence status Issued (active); first licensed March 6, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110910
- Licence holder
- Apyx Medical CorporationClearwater, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 6, 2024
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- APYX ONE CONSOLE
- DISPOSABLE SPLIT PAD RETURN ELECTRODE
- FOOTSWITCH BIPOLAR
- FOOTSWITCH MONOPOLAR
- HELIUM GAS REGULATOR WITH DIGITAL GAS PRESSURE SENSOR
- RENUVION / J-PLASMA FOOTSWITCH DUAL PEDAL
- RENUVION / J-PLASMA HELIUM GAS REGULATOR
- RENUVION MICRO HANDPIECE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.