Data / Medical devices / United Kingdom / Alesi Surgical Ltd
Alesi Surgical Ltd: FDA-registered device maker in Cardiff, United Kingdom, 7 510(k) clearances
Alesi Surgical Ltd is registered with the FDA (registration 3012582478) in Cardiff, United Kingdom. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012582478
- Address
- Cardiff Medicentre Heath Park, Cardiff, United Kingdom, CF144UJ
- Owner or operator
- Alesi Surgical Ltd (10054476)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 23, 2017
- Registered through
- 2026
- Brand names listed
- ULTRAVISION, Ultravision, Ultravision Visual Field Clearing System, Ultravision2 Integrated Monopolar L-Hook (H/S), Ultravision2 IonPencil, Ultravision2 System, Ultravision Visual Field Clearing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Surgical Smoke Precipitator | PQM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 12, 2024 | K240868 | Ultravision2 IonPencil | PQM | Substantially Equivalent | Alesi Surgical Limited | accessdata.fda.gov |
| October 31, 2023 | K231298 | Ultravision2 System Integrated Monopolar L-Hook (H/S) | PQM | Substantially Equivalent | Alesi Surgical, Ltd. | accessdata.fda.gov |
| October 31, 2023 | K231238 | Ultravision2 System | PQM | Substantially Equivalent | Alesi Surgical, Ltd. | accessdata.fda.gov |
| May 4, 2020 | K200035 | Ultravision Visual Field Clearing System | PQM | Substantially Equivalent | Alesi Surgical, Ltd. | accessdata.fda.gov |
| September 7, 2018 | K182053 | Ultravision Visual Field Clearing System | PQM | Substantially Equivalent | Alesi Surgical, Ltd. | accessdata.fda.gov |
| May 26, 2017 | K170178 | Ultravision Visual Field Clearing System | PQM | Substantially Equivalent | Alesi Surgical, Ltd. | accessdata.fda.gov |
| December 20, 2016 | DEN150022 | Ultravision Visual Clearing System | PQM | Unknown | Alesi Surgical, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.