Sonendo GentleWave System— 510(k) K190359
Substantially EquivalentSonendo, Inc.
FDA 510(k) clearance K190359 for Sonendo GentleWave System, Substantially Equivalent on 2019-03-16. Applicant: Sonendo, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonendo, Inc.
- Product code
- Code ELC
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Laguna Hills, CA, US
Recent devices under product code ELC
view allMore clearances from Sonendo, Inc.
view allAdverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K190359
K-number listed on FDA's recall record- Z-0233-2023 — GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
- Z-0234-2023 — GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- Z-2162-2020 — GENTLEWAVE REF: FG-002-0001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190359.
Data sourced from openFDA. This site is unofficial and independent of the FDA.