K182053 is an FDA 510(k) clearance for the Ultravision™ Visual Field Clearing System. This device is classified as a Surgical Smoke Precipitator (Class II - Special Controls, product code PQM).
Submitted by Alesi Surgical, Ltd. (Cardiff, GB). The FDA issued a Cleared decision on September 7, 2018, 38 days after receiving the submission on July 31, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5050. The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools..
| 510(k) Number | K182053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2018 |
| Decision Date | September 07, 2018 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PQM - Surgical Smoke Precipitator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5050 |
| Definition | The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools. |