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510(k) K200035

Ultravision Visual Field Clearing System by Alesi Surgical, Ltd. — Product Code PQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2020
Date Received
January 8, 2020
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.

  • K231238 — Ultravision2™ System (October 31, 2023)
  • K231298 — Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (October 31, 2023)
  • 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)
  • K231238 — Ultravision2™ System (October 31, 2023)
  • K231298 — Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ (October 31, 2023)
  • 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)