K160905 is an FDA 510(k) clearance for the Sonendo GentleWave System. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).
Submitted by Sonendo, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on June 3, 2016, 63 days after receiving the submission on April 1, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K160905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2016 |
| Decision Date | June 03, 2016 |
| Days to Decision | 63 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC - Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |