Alesi Surgical Ltd
Cardiff Cardiff, GB
ALESI SURGICAL LTD appears in FDA device records in Cardiff Cardiff, GB. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Alesi Surgical Ltd between 2016 and 2024. The busiest year on record is 2023, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240868 | Ultravision2™ IonPencil | PQM | Substantially Equivalent | |
| K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | PQM | Substantially Equivalent | |
| K231238 | Ultravision2™ System | PQM | Substantially Equivalent | |
| K200035 | Ultravision Visual Field Clearing System | PQM | Substantially Equivalent | |
| K182053 | Ultravision™ Visual Field Clearing System | PQM | Substantially Equivalent | |
| K170178 | Ultravision Visual Field Clearing System | PQM | Substantially Equivalent | |
| DEN150022 | Ultravision Visual Clearing System | PQM | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012582478 | 3012582478 | ALESI SURGICAL LTD | Cardiff Medicentre, Cardiff CF144UJ GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain