# K231298: Ultravision2™ System Integrated Monopolar L-Hook (H/S)™

- Pathway: 510(k) (Traditional)
- Applicant: Alesi Surgical, Ltd.
- Decided: Oct 31, 2023 after 180 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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.
- K964175: Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series Electrodes, Valleylab, Inc. (1996) Summary page 5.
- K153265: New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated, New Deantronics Taiwan, Ltd. (2016) Summary page 5.

## Most influential descendants
- K240868: Ultravision2™ IonPencil (2024), 0 descendants of its own

## Indications for use
The Ultravision 2™ Integrated Monopolar L-Hook (H/S)™ is intended to be used with applications in surgical procedures to facilitate cutting, coagulating of tissue, in combination with the clearance of smoke and other particulate matter that is created during laparoscopic surgery.

Source page: https://510kreport.com/device/K231298
Methodology: https://510kreport.com/methodology