K203302 is an FDA 510(k) clearance for the GentleWave X. 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 February 5, 2021, 88 days after receiving the submission on November 9, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.
| 510(k) Number | K203302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2020 |
| Decision Date | February 05, 2021 |
| Days to Decision | 88 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 |