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Sign in to claim this brandSONENDO, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 26061 Merit Circle, Laguna Hills, CA, 92653
- Website
- sonendo.com
- —
- —
- [email protected]
- Phone
- 8447663636
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3010817521
- DUNS Number
- 828894373
Catalogue (54)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GentleWave X | K203302 | FDA 510(k) | Class II | Active |
| Sonendo Gentle Wave System | K153157 | FDA 510(k) | Class II | Active |
| Sonendo Endotherapy System | K130025 | FDA 510(k) | Class II | Active |
| Sonendo Filling Material 5C | K211995 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 14, 2022 | Z-0234-2023 | — | open, classified | Procedure Instruments with erroneous unit carton labels. |
| Oct 14, 2022 | Z-0233-2023 | — | open, classified | Procedure Instruments with erroneous unit carton labels. |
| Oct 23, 2019 | Z-2162-2020 | — | terminated | The console would continue to run for extended period when the foot pedal was released. |