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510(k) DEN150022

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

DEN150022 is an FDA 510(k) premarket notification submitted by Alesi Surgical, Ltd. for the device "Ultravision Visual Clearing System". The FDA issued a decision of De Novo Granted on December 20, 2016. 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
DENG (De Novo Granted)
Decision Date
December 20, 2016
Date Received
May 26, 2015
Clearance Type
Direct
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)
  • K182053 — Ultravision™ Visual Field Clearing System (September 7, 2018)
  • K170178 — Ultravision Visual Field Clearing System (May 26, 2017)

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)
  • K182053 — Ultravision™ Visual Field Clearing System (September 7, 2018)
  • K170178 — Ultravision Visual Field Clearing System (May 26, 2017)

FDA data resources