K143448 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 May 1, 2015, 150 days after receiving the submission on December 2, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K143448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2014 |
| Decision Date | May 01, 2015 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELC - Scaler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4850 |