510(k) K240868

Ultravision2 IonPencil by Alesi Surgical Limited — Product Code PQM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 12, 2024
Date Received: March 29, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Surgical Smoke Precipitator
Device Class: Class II
Regulation Number: 878.5050
Review Panel: HO
Submission Type

The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.

Other clearances for product code PQM

K231238 — Ultravision2 System (October 31, 2023)
K231298 — Ultravision2 System Integrated Monopolar L-Hook (H/S) (October 31, 2023)
K200035 — Ultravision Visual Field Clearing System (May 4, 2020)
K182053 — Ultravision Visual Field Clearing System (September 7, 2018)
K170178 — Ultravision Visual Field Clearing System (May 26, 2017)
DEN150022 — Ultravision Visual Clearing System (December 20, 2016)