QZN

Multi-Photon Imaging

Product code
QZN
Device name
Multi-Photon Imaging
Device class
Class 2
21 CFR
21 CFR 878.4580
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification definition

To provide visible illumination of the surgical field or the patient

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-22.

NumberDecision dateApplicantDevice nameSummary
K2327892023-12-22Enspectra Health, Inc.VIO System (V-1000)PDF

1 summaries are archived here for direct download.

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