# K231238: Ultravision2™ System

- Pathway: 510(k) (Traditional)
- Applicant: Alesi Surgical, Ltd.
- Decided: Oct 31, 2023 after 186 days
- Product code: PQM (Surgical Smoke Precipitator)
- Device class: 2
- Regulation: 21 CFR 878.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN150022 (2016). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200035: Ultravision Visual Field Clearing System, Alesi Surgical, Ltd. (2020) Summary page 5.

## Indications for use
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery. The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.

Source page: https://510kreport.com/device/K231238
Methodology: https://510kreport.com/methodology