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PQM — Surgical Smoke Precipitator Class II

FDA Device Classification

Classification Details

Product Code
PQM
Device Class
Class II
Regulation Number
878.5050
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240868alesi surgical limitedUltravision2™ IonPencilAugust 12, 2024
K231298alesi surgicalUltravision2™ System Integrated Monopolar L-Hook (H/S)™October 31, 2023
K231238alesi surgicalUltravision2™ SystemOctober 31, 2023
K200035alesi surgicalUltravision Visual Field Clearing SystemMay 4, 2020
K182053alesi surgicalUltravision™ Visual Field Clearing SystemSeptember 7, 2018
K170178alesi surgicalUltravision Visual Field Clearing SystemMay 26, 2017
DEN150022alesi surgicalUltravision Visual Clearing SystemDecember 20, 2016