Sonendo GentleWave System
FDA 510(k) clearance K160905 · decided 2016-06-03
Clearance details
- K-number
- K160905
- Device name
- Sonendo GentleWave System
- Applicant
- Sonendo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-01
- Decision date
- 2016-06-03
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sonendo
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.