Product code PQM— General, Plastic Surgery
Ultravision Visual Field Clearing System
- Classification name
- Surgical Smoke Precipitator
- Device class
- Class 2
- Regulation
- 21 CFR 878.5050
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 7
- First cleared
- Most recent
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.”
Market context for product code PQM
FDA has cleared devices under product code PQM between 2016 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2023
- 2020
- 2018
- 2017
- 2016
Top applicants under product code PQM
Recent clearances under product code PQM
- K240868 — Ultravision2 IonPencil
- K231238 — Ultravision2 System
- K231298 — Ultravision2 System Integrated Monopolar L-Hook (H/S)
- K200035 — Ultravision Visual Field Clearing System
- K182053 — Ultravision Visual Field Clearing System
- K170178 — Ultravision Visual Field Clearing System
- DEN150022 — Ultravision Visual Clearing System
Data sourced from openFDA. This site is unofficial and independent of the FDA.