510(k) K203302 ยท ELC Scaler, Ultrasonic
GentleWave X
| Applicant | Sonendo, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Feb 5, 2021 |
| Received | Nov 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203302
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.