QCR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Wound Autofluorescence Imaging Device
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4165
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| MolecuLight i:X (DEN180008) | MolecuLight, Inc. | 2018-07-31 |
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