510(k) DEN150022
- Device
- Ultravision Visual Clearing System
- Applicant
- Alesi Surgical, Ltd.
- 510(k) number
- DEN150022
- Product code
- PQM
- Decision
- Unknown (DENG)
- Decision date
- 2016-12-20
- Date received
- 2015-05-26
- Regulation
- 878.5050
- Classification name
- Surgical Smoke Precipitator
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- DOMINIC GRIFFITHS
- Address
- Suite 18, Cardiff Medical Centre, Heath Park Caediff GB
FDA Registration Numbers#
- 3012582478
- 3008824097
- 3004530184
- 3007607999
- 3008559295
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PQM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240868 | Ultravision2™ IonPencil | Alesi Surgical Limited | 2024-08-12 |
| 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 |