FDA product code QZN: Multi-Photon Imaging
QZN is the FDA product code for multi-photon imaging. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under QZN, 1 in the last five years. The average 510(k) review took 102 days (median 102).
Definition
To provide visible illumination of the surgical field or the patient
Classification
| Field | Value |
|---|---|
| Device name | Multi-Photon Imaging |
| Device class | Class II |
| Regulation | 21 CFR 878.4580 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QZN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 102 |
Compare with all 510(k) review times · Search every QZN clearance
Top QZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Enspectra Health, Inc. | 1 | 2023-12-22 |
Most recent QZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232789 | Enspectra Health, Inc. | VIO System (V-1000) | 2023-12-22 | 102 |
Recalls for QZN devices
openFDA lists no recalls for product code QZN.
Frequently asked questions
What is FDA product code QZN?
QZN is the FDA product code for multi-photon imaging. It is a Class II device, regulated under 21 CFR 878.4580 and reviewed by the General and Plastic Surgery panel.
What device class is QZN?
Class II, regulation 21 CFR 878.4580. Typical premarket route: 510(k).
How long does a 510(k) take for product code QZN?
Across 1 cleared submissions the average was 102 days from receipt to decision (median 102).
Which companies have the most QZN clearances?
Enspectra Health, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QZN
- Run a recall and safety report across every QZN manufacturer
- Watch product code QZN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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