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510(k) K231238

Ultravision2™ System by Alesi Surgical, Ltd. — Product Code PQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2023
Date Received
April 28, 2023
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 by Alesi Surgical, Ltd.

  • 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)

Other clearances for product code PQM

  • K240868 — Ultravision2™ IonPencil (August 12, 2024)
  • 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)