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PQM

Surgical Smoke Precipitator

Product code
PQM
Device name
Surgical Smoke Precipitator
Device class
Class 2
21 CFR
21 CFR 878.5050
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2024-08-12.

NumberDecision dateApplicantDevice nameSummary
K2408682024-08-12Alesi Surgical LimitedUltravision2™ IonPencilPDF
K2312382023-10-31Alesi Surgical, Ltd.Ultravision2™ SystemFDA
K2312982023-10-31Alesi Surgical, Ltd.Ultravision2™ System Integrated Monopolar L-Hook (H/…FDA

1 summaries are archived here for direct download.

Official FDA classification page: PQM
Classification and pathway per current FDA publications. Data from openFDA (CC0).