Wound Autofluorescence Imaging Device
The Wound Autofluorescence Imaging Device is a tool used to view autofluorescence images from skin wounds exposed to an excitation light, providing a visual aid for wound assessment; it is not intended to provide quantitative or diagnostic information. It is classified as FDA Class 1, subject only to general controls, with no premarket notification required. The product code is QCR under regulation 878.4165 in the General and Plastic Surgery specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QCR
- Device Class
- FDA class 1
- Regulation Number
- 878.4165
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN180008 | MolecuLight i:X | Jul 31, 2018 | Unknown | MolecuLight, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.