Data / Medical devices / United States / Sonendo, Inc.
Sonendo, Inc.: FDA-registered device maker in Laguna Hills, CA, United States, 2 510(k) clearances
Sonendo, Inc. is registered with the FDA (registration 3010817521) in Laguna Hills, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 5, 2021. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010817521
- Address
- 26061 Merit Circle Suite 101, Laguna Hills, CA, United States, 92653
- Owner or operator
- Sonendo, Inc. (10046931)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 7, 2018
- Registered through
- 2026
- Brand names listed
- Ergo Arm, GentleWave System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 5, 2021 | K203302 | GentleWave X | ELC | Substantially Equivalent | Sonendo, Inc. | accessdata.fda.gov |
| June 3, 2016 | K160905 | Sonendo GentleWave System | ELC | Substantially Equivalent | Sonendo, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 14, 2022 | 91045 | Class II | Ongoing | GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 | Procedure Instruments with erroneous unit carton labels. | accessdata.fda.gov |
| October 23, 2019 | 85593 | Class II | Terminated | GENTLEWAVE REF: FG-002-0001 | The console would continue to run for extended period when the foot pedal was released. | accessdata.fda.gov |
Compare with other makers
- All makers of Scaler, Ultrasonic
- All makers of Accessories, Retractor, Dental
- All makers of File, Pulp Canal, Endodontic
Updated November 14, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.