K241902
- 510(k) number
- K241902
- Device name
- Edison System
- Applicant
- HistoSonics, Inc. MN · US
- Product code
- QGM — Focused Ultrasound System For Non-Thermal, Mechanica
- Decision date
- 2024-10-30
- Date received
- 2024-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K241902.pdf
Official FDA record: K241902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.