QZN
- 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
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232789 | 2023-12-22 | Enspectra Health, Inc. | VIO System (V-1000) |
Official FDA classification page: QZN
Classification and pathway per current FDA publications. Data from openFDA (CC0).