Sonendo GentleWave System
FDA 510(k) clearance K190359 · decided 2019-03-16
Clearance details
- K-number
- K190359
- Device name
- Sonendo GentleWave System
- Applicant
- Sonendo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-15
- Decision date
- 2019-03-16
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 recall (Z-0233-2023) | Sonendo Inc | 2022-11-14 |
| GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-P recall (Z-0234-2023) | Sonendo Inc | 2022-11-14 |