510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QZNClass II

Multi-Photon Imaging

21 CFR 878.4580 / General, Plastic Surgery
FDA source (opens on fda.gov)

QZN is the FDA product code for Multi-Photon Imaging, a class II device type, regulated under 21 CFR 878.4580. FDA's definition for this code reads: "To provide visible illumination of the surgical field or the patient". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QZN
Device name
Multi-Photon Imaging
FDA definition
To provide visible illumination of the surgical field or the patient
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QZN

By decision year
1 clearance under product code QZN with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QZN by decision year
YearClearances
20231

Applicants with the most clearances

Product code QZN
Applicants holding the most 510(k) clearances under product code QZN
ApplicantClearances
Enspectra Health, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QZN.