510(k) Report

FDA product code · General and plastic surgery

Multi-Photon Imaging

QZNClass II21 CFR 878.4580510(k) required1 decision since 20230 recalls

1 FDA decision since 2023. 510(k) reviews decided 2021–2025 took a median of 102 days (half between 102 and 102). No recall names this code.

To provide visible illumination of the surgical field or the patient

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of QZN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QZN

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QZN

Too few QZN 510(k)s in any year since 2007 to give a median.

Recalls per year · QZN

No recall names QZN since 2007.

Adverse event reports per year · QZN

No MAUDE report names QZN since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — QZN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QZN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 878.4580.