510(k) K240868
- Device
- Ultravision2? IonPencil
- Applicant
- Alesi Surgical Limited
- 510(k) number
- K240868
- Product code
- PQM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-12
- Date received
- 2024-03-29
- Regulation
- 878.5050
- Classification name
- Surgical Smoke Precipitator
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Pravin Patel
- Address
- Cardiff Medicentre, Heath Park, Cardiff, Cf14 4uj Cardiff GB
FDA Registration Numbers#
- 3012582478
- 3008824097
- 3004530184
- 3007607999
- 3008559295
Source Documents#
Other 510(k) Records For Product Code PQM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231238 | Ultravision2™ System | Alesi Surgical, Ltd. | 2023-10-31 |
| K231298 | Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ | Alesi Surgical, Ltd. | 2023-10-31 |
| K200035 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2020-05-04 |
| K182053 | Ultravision™ Visual Field Clearing System | Alesi Surgical, Ltd. | 2018-09-07 |
| K170178 | Ultravision Visual Field Clearing System | Alesi Surgical, Ltd. | 2017-05-26 |
| DEN150022 | Ultravision Visual Clearing System | Alesi Surgical, Ltd. | 2016-12-20 |