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510(k) K200035

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

K200035 is an FDA 510(k) premarket notification submitted by Alesi Surgical, Ltd. for the device "Ultravision Visual Field Clearing System". The FDA issued a decision of Substantially Equivalent on May 4, 2020. The device falls under product code PQM (Surgical Smoke Precipitator), a Class II device regulated under 21 CFR 878.5050. Alesi Surgical, Ltd. has at least 5 other 510(k) clearances on record.

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)

FDA data resources