510(k) K160905
K160905 is an FDA 510(k) premarket notification submitted by Sonendo, Inc. for the device "Sonendo GentleWave System". The FDA issued a decision of Substantially Equivalent on June 3, 2016. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Sonendo, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2016
- Date Received
- April 1, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type