Ultravision2™ System
FDA 510(k) clearance K231238 · decided 2023-10-31
Clearance details
- K-number
- K231238
- Device name
- Ultravision2™ System
- Applicant
- Alesi Surgical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-28
- Decision date
- 2023-10-31
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- PQM
- Device class
- 2
- Regulation number
- 878.5050
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Newbury, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ultravision2™ IonPencil (K240868) | Alesi Surgical Limited | 2024-08-12 |
| Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (K231298) | Alesi Surgical, Ltd. | 2023-10-31 |
| Ultravision Visual Field Clearing System (K200035) | Alesi Surgical, Ltd. | 2020-05-04 |
| Ultravision™ Visual Field Clearing System (K182053) | Alesi Surgical, Ltd. | 2018-09-07 |
| Ultravision Visual Field Clearing System (K170178) | Alesi Surgical, Ltd. | 2017-05-26 |
| Ultravision Visual Clearing System (DEN150022) | Alesi Surgical, Ltd. | 2016-12-20 |
Recalls involving this device
No recalls on record reference this clearance.