| DeNovo ID | DEN150022 |
| Device Name: | Ultravision Visual Clearing System |
| Classification | Surgical Smoke Precipitator |
| Applicant | Alesi Surgical Ltd. suite 18, Cardiff Medical Centre, Heath Park Caediff, GB |
| Contact | Dominic Griffiths |
| Product Code | PQM |
| CFR Regulation Number | 878.5050 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General Hospital |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2015-05-26 |
| Decision Date | 2016-12-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |