The following data is part of a premarket notification filed by Sonendo, Inc with the FDA for Gentlewave X.
| Device ID | K203302 |
| 510k Number | K203302 |
| Device Name: | GentleWave X |
| Classification | Scaler, Ultrasonic |
| Applicant | Sonendo, Inc 26061 Merit Circle, Suite 102 Laguna Hills, CA 92653 |
| Contact | Lyle Verplanck |
| Correspondent | Lyle Verplanck Sonendo, Inc 26061 Merit Circle, Suite 102 Laguna Hills, CA 92653 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-09 |
| Decision Date | 2021-02-05 |