The following data is part of a premarket notification filed by Alesi Surgical Ltd. with the FDA for Ultravision Visual Field Clearing System.
| Device ID | K170178 |
| 510k Number | K170178 |
| Device Name: | Ultravision Visual Field Clearing System |
| Classification | Surgical Smoke Precipitator |
| Applicant | Alesi Surgical Ltd. Cardiff MediCentre, Heath Park Cardiff, GB Cf14 4uj |
| Contact | David Broderick |
| Correspondent | David Broderick Alesi Surgical Ltd. Cardiff MediCentre, Heath Park Cardiff, GB Cf14 4uj |
| Product Code | PQM |
| CFR Regulation Number | 878.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-19 |
| Decision Date | 2017-05-26 |
| Summary: | summary |