# K240868: Ultravision2™ IonPencil

- Pathway: 510(k) (Traditional)
- Applicant: Alesi Surgical Limited
- Decided: Aug 12, 2024 after 136 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: 5 generations back to DEN150022 (2016). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231298: Ultravision2™ System Integrated Monopolar L-Hook (H/S)™, Alesi Surgical, Ltd. (2023) Summary page 4.
- K200035: Ultravision Visual Field Clearing System, Alesi Surgical, Ltd. (2020) Summary page 4.
- K965054: Pencil, Megadyne Medical Products, Inc. (1997) Summary page 4.
- K081791: E-Z Clean Electrosurgical Electrode, Megadyne Medical Products, Inc. (2008) Summary page 4.

## Indications for use
The Ultravision2™ System is indicated for use in surgery including laparoscopic surgery. • The Ultravision2™ Generator is intended to interface directly with the electrosurgical generator and serve as a pass-through for HF energy to HF electrosurgical instruments, to manage surgical smoke produced by energy-based instruments, and is indicated for use in surgery including laparoscopic surgery. • The Ionwand™ Pack is intended to be used to manage surgical smoke and is indicated for use in surgery including laparoscopic surgery. • The Ultravision™ 5mm Trocar is intended to be used to establish a path of entry for instruments and includes an Ionwand to manage surgical smoke, and is indicated for laparoscopic surgery. • The Integrated Monopolar L-Hook (H/S)™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during laparoscopic surgical procedures, and is indicated for use in laparoscopic surgery. • The IonPencil™ is intended to be used to facilitate the cutting and coagulation of soft tissue, to manage surgical smoke during general surgical procedures, and is indicated for use in surgery.

Source page: https://510kreport.com/device/K240868
Methodology: https://510kreport.com/methodology