K231238
- 510(k) number
- K231238
- Device name
- Ultravision2 System
- Applicant
- Alesi Surgical, Ltd. NH · US
- Product code
- PQM — Surgical Smoke Precipitator
- Decision date
- 2023-10-31
- Date received
- 2023-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K231238.pdf
Official FDA record: K231238
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.