QCR — Wound Autofluorescence Imaging Device Class I
FDA product code QCR covers "Wound Autofluorescence Imaging Device", a Class I medical device regulated under 21 CFR 878.4165. 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
- QCR
- Device Class
- Class I
- Regulation Number
- 878.4165
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180008 | moleculight | MolecuLight i:X | July 31, 2018 |