QZN — Multi-Photon Imaging Class II
FDA product code QZN covers "Multi-Photon Imaging", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QZN
- Device Class
- Class II
- Regulation Number
- 878.4580
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
To provide visible illumination of the surgical field or the patient
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232789 | enspectra health | VIO System (V-1000) | December 22, 2023 |