Ultravision2 IonPencil
Ultravision2 IonPencil combines monopolar electrosurgical cutting and coagulation with smoke management during open surgery. Two emitters clear the visual field by electrostatic…
Ultravision2 IonPencil combines monopolar electrosurgical cutting and coagulation with smoke management during open surgery. Two emitters clear the visual field by electrostatic precipitation when the electrosurgical function is activated.
The handpiece connects only to an Ultravision2 generator, which receives high-frequency energy from a separate electrosurgical generator. Yellow cut and blue coagulation buttons control activation, with foot-switch operation available through the connected electrosurgical generator.
Listed Item
The Ultravision2 IonPencil™ is a bifunctional open surgery device that combines proprietary smoke management (via visual field clearing) and monopolar HF tissue cutting and coagulation in a single device. It’s addition to the Ultravision2 System adds the general open procedure capability to the Ultravision2™ indications of use along with the new single use accessory.
Blade and Synchronization
The single-use accessory carries a 69 mm PTFE-coated blade. Smoke clearing switches off after a short delay when cutting or coagulation stops; that delay is set through the Ultravision2 generator interface.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Alesi Surgical Ltd, United Kingdom |
|---|---|
| FDA product code | PQM |
| Device type | Surgical Smoke Precipitator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K240868 |
| Record published | 2024-08-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 40, shipper box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DPD-007-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltravisionTM | Alesi Surgical Ltd | 11 |
| UltravsionTM | Alesi Surgical Ltd | 1 |
| Ultravision2 Generator | Alesi Surgical Ltd | 1 |
| Ultravision2 Integrated Monopolar L Hook (H/S) | Alesi Surgical Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240868 | 2024-08-12 |
| K231298 | 2023-10-31 |
| K231238 | 2023-10-31 |
| K200035 | 2020-05-04 |
| K182053 | 2018-09-07 |
| K170178 | 2017-05-26 |
| DEN150022 | 2016-12-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.