510(k) K190359 ยท ELC Scaler, Ultrasonic
Sonendo GentleWave System
| Applicant | Sonendo, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Mar 16, 2019 |
| Received | Feb 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2022 | Sonendo Inc GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 Open, Classified |
ELC | None listed |
| Nov 14, 2022 | Sonendo Inc GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 Open, Classified |
ELC | None listed |
| Oct 23, 2019 | Sonendo Inc GENTLEWAVE REF: FG-002-0001 Terminated |
ELC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.