Home / 510(k) Clearances / K182053

510(k) K182053

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

K182053 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 September 7, 2018. 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
September 7, 2018
Date Received
July 31, 2018
Clearance Type
Special
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)
  • K200035 — Ultravision Visual Field Clearing System (May 4, 2020)
  • 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)
  • K200035 — Ultravision Visual Field Clearing System (May 4, 2020)
  • K170178 — Ultravision Visual Field Clearing System (May 26, 2017)
  • DEN150022 — Ultravision Visual Clearing System (December 20, 2016)

FDA data resources