The following data is part of a premarket notification filed by Sonendo, Inc. with the FDA for Sonendo Gentlewave System.
| Device ID | K160905 |
| 510k Number | K160905 |
| Device Name: | Sonendo GentleWave System |
| Classification | Scaler, Ultrasonic |
| Applicant | SONENDO, INC. 26061 MERIT CIRCLE, SUITE 102 Laguna Hills, CA 92653 |
| Contact | Dan W. Miller |
| Correspondent | Dan W. Miller SONENDO, INC. 26061 MERIT CIRCLE, SUITE 102 Laguna Hills, CA 92653 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-06-03 |