K240868 is an FDA 510(k) clearance for the Ultravision2™ IonPencil. This device is classified as a Surgical Smoke Precipitator (Class II - Special Controls, product code PQM).
Submitted by Alesi Surgical Limited (Cardiff, GB). The FDA issued a Cleared decision on August 12, 2024, 136 days after receiving the submission on March 29, 2024.
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 | K240868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2024 |
| Decision Date | August 12, 2024 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| 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. |