FDA Product Code
FDA Product Code PQM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5050
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240868 | Ultravision2 IonPencil | Alesi Surgical Limited | 2024-08-12 | Traditional | PDF ↗ |
| K231238 | Ultravision2 System | Alesi Surgical, Ltd. | 2023-10-31 | Traditional | PDF ↗ |
| K231298 | Ultravision2 System Integrated Monopolar L-Hook (H/S) | Alesi Surgical, Ltd. | 2023-10-31 | Traditional | PDF ↗ |
| K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020-05-04 | Traditional | PDF ↗ |
| K182053 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2018-09-07 | Special | PDF ↗ |
| K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017-05-26 | Traditional | PDF ↗ |
| DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016-12-20 | Direct | — |
Product code PQM · Class II · General, Plastic Surgery. Data: openFDA.