# K200035: Ultravision Visual Field Clearing System

- Pathway: 510(k) (Traditional)
- Applicant: Alesi Surgical, Ltd.
- Decided: May 4, 2020 after 117 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: 3 generations back to DEN150022 (2016). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182053: Ultravision™ Visual Field Clearing System, Alesi Surgical, Ltd. (2018) Summary page 4.

## Most influential descendants
- K231298: Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (2023), 1 descendant of its own
- K240868: Ultravision2™ IonPencil (2024), 0 descendants of its own
- K231238: Ultravision2™ System (2023), 0 descendants of its own

## Indications for use
The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during surgery, including laparoscopic surgery. The Ultravision™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.

Source page: https://510kreport.com/device/K200035
Methodology: https://510kreport.com/methodology