DEN220087
- 510(k) number
- DEN220087
- Device name
- Edison System
- Applicant
- HistoSonics, Inc. MN · US
- Product code
- QGM — Focused Ultrasound System For Non-Thermal, Mechanica
- Decision date
- 2023-10-06
- Date received
- 2022-12-02
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General, Plastic Surgery
Official FDA record: DEN220087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.