Medical device licence · 101958 · Class 2
GENTLEWAVE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101958
- Licence holder
- Sonendo, Inc.Laguna Hills, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 25, 2018
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENTLEWAVE APM MATRIX
- GENTLEWAVE APM PROCEDURE INSTRUMENT WITH MATRIX
- GENTLEWAVE CLEANFLOW PROCEDURE INSTRUMENT FOR CARIES
- GENTLEWAVE CONSOLE
- GENTLEWAVE DEPTH GAUGES
- GENTLEWAVE G4 FOR CARIES
- GENTLEWAVE G4 SYSTEM
- GENTLEWAVE MOLAR MATRIX
- GENTLEWAVE MOLAR PROCEDURE INSTRUMENT
- GENTLEWAVE SEALING CAP
- MOLAR CROSSFIRE PI WITH MATRIX
- POSTERIOR CLEANFLOW PROCEDURE INSTRUMENT WITH MATRIX
- POSTERIOR MATRICES
- PREMOLAR CROSSFIRE PI WITH MATRIX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.