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): 7

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.

Number	Decision date	Applicant	Device name	Summary
K240868	2024-08-12	Alesi Surgical Limited	Ultravision2 IonPencil	PDF
K231238	2023-10-31	Alesi Surgical, Ltd.	Ultravision2 System	FDA
K231298	2023-10-31	Alesi 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).