UltravisionTM
UltravisionTM Visual Field Clearing System
1manufacturer
11catalogue numbers in this listing
7510(k) clearances naming this product code
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) | DEN150022 |
| Record published | 2017-05-12 |
| Record revised | 2022-04-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 85 % RH; Storage environment temperature -10 to 40 °C |
| Packaging | Pack of 12, pack of 10, pack of 6, pack of 20, pack of 8 |
| Sizes | Length 0.75 to 1.5 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UltravisionTM Generator | In distribution | |
| Mains Converter | In distribution | |
| Ultravision TM 5mm Trocar | In distribution | |
| Patient Return Adaptor 1.5M (solid) | Length 1.5 m | In distribution |
| UltravisionTM System Starter Pack | In distribution | |
| Ultravision Battery Recharging Station | In distribution | |
| UltravsionTM Power Supply Unit | In distribution | |
| Patient Return Adaptor 0.75m (Split) | Length 0.75 m | In distribution |
| IonwandTM Sterile Pack | In distribution | |
| Patient Return Adaptor 1.5m (Split) | Length 1.5 m | In distribution |
| Patient Return Adaptor Solid | Length 0.75 m | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltravsionTM | Alesi Surgical Ltd | 1 |
| Ultravision2 IonPencil | 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.