510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182053Substantially Equivalent

Ultravision™ Visual Field Clearing System

Alesi Surgical Ltd, Cardiff, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182053 is the FDA 510(k) clearance record for Ultravision™ Visual Field Clearing System, a class II device, cleared for Alesi Surgical, Ltd. on under FDA product code PQM (Surgical Smoke Precipitator). FDA's definition for product code PQM reads: "The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools". FDA records list 7 510(k) clearances for Alesi Surgical, Ltd., from to . As of , FDA records show no recalls naming K182053.

Clearance record

Decision date
Received
(38 days to decision)
Product code
PQM Surgical Smoke Precipitator
Regulation
21 CFR 878.5050
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Alesi Surgical, Ltd. Cardiff Medicentre, Heath Park, Cardiff, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PQM

Trailing 12 months

FDA records hold no clearances under product code PQM in the trailing twelve months.

FDA records show no clearances under product code PQM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260