510(k) · Cleared
ClearedUltravision2™ IonPencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alesi Surgical Limited · PQM Surgical Smoke Precipitator
Cleared on Aug 12, 2024 as substantially equivalent to K231298 (Alesi Surgical, Ltd., 2023) and 3 other predicates after a 136-day review. Its family tree reaches back 5 generations to 2016.
- Decided
- Aug 12, 2024
- Review
- 136 days
- Class
- Class II
- Product code
- PQM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to DEN150022 (2016). 16 ancestors in all, the oldest K780977 (1978). No later device cites it as a predicate yet.
- Root · 5 generations backDEN150022 Ultravision Visual Clearing SystemAlesi Surgical, Ltd. · 2016
- 4 generations backK170178 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2017
- 3 generations backK182053 Ultravision™ Visual Field Clearing SystemAlesi Surgical, Ltd. · 2018
- 2 generations backK200035 Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. · 2020
- 1 generation backK231298 Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Alesi Surgical, Ltd. · 2023
- This deviceK240868 Ultravision2™ IonPencilAlesi Surgical Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016 | — |
| −4 | K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017 | — |
| −3 | K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018 | — |
| −2 | K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020 | — |
| −1 | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023 | — |
| 0 (this device) | K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PQM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PQM device
- #1 K231298 Ultravision2™ System Integrated Monopolar…score 10.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™Summary page 4…GEI Regulatory Class: Class II Predicate Device: Ultravision 2 System including Integrated Monopolar L-Hook (H/S) (K231298) Ultravision™ Visual Field Clearing System (K200035) Megadyne Pencil (K… | 2023 |
| * | K200035 | Ultravision Visual Field Clearing SystemSummary page 4…ision 2 System including Integrated Monopolar L-Hook (H/S) (K231298) Ultravision™ Visual Field Clearing System (K200035) Megadyne Pencil (K965054) and Megadyne EZ Clean Electrosurgical Electr… | 2020 |
| * | K965054 | PencilSummary page 4…/S) (K231298) Ultravision™ Visual Field Clearing System (K200035) Megadyne Pencil (K965054) and Megadyne EZ Clean Electrosurgical Electrode (K081791) Page 1 of 9 Indicatio… | 1997 |
| * | K081791 | E-Z Clean Electrosurgical ElectrodeSummary page 4…sual Field Clearing System (K200035) Megadyne Pencil (K965054) and Megadyne EZ Clean Electrosurgical Electrode (K081791) Page 1 of 9 Indications for Use: The Ultravision2™ System is indicated for use in surgery including laparosc… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 16 ancestors have a recall of any class.
How does its category compare?
All PQM devicesPQM Surgical Smoke Precipitator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PQM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PQM
Too few PQM 510(k)s in any year since 2007 to give a median.
Recalls per year · PQM
No recall names PQM since 2007.
Adverse event reports per year · PQM
4in 2018
MAUDE reports naming product code PQM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (178 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240868 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240868: Ultravision2™ IonPencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240868
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026