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510(k) K240868

Ultravision2™ IonPencil by Alesi Surgical Limited — Product Code PQM

K240868 is an FDA 510(k) premarket notification submitted by Alesi Surgical Limited for the device "Ultravision2™ IonPencil". The FDA issued a decision of Substantially Equivalent on August 12, 2024. The device falls under product code PQM (Surgical Smoke Precipitator), a Class II device regulated under 21 CFR 878.5050.

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)

FDA data resources