510(k) K160905 ยท ELC Scaler, Ultrasonic
Sonendo GentleWave System
| Applicant | Sonendo, Inc., Laguna Hills CA, US |
| Decision | Substantially Equivalent, Jun 3, 2016 |
| Received | Apr 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160905
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.