QCR · Wound Autofluorescence Imaging Device
General, Plastic Surgery · 21 CFR 878.4165 · Class 1
Overview
| Product Code | QCR |
|---|---|
| Device Name | Wound Autofluorescence Imaging Device |
| Regulation | 21 CFR 878.4165 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN180008 | MolecuLight i:X | MolecuLight, Inc. | Jul 31, 2018 | DENG |
Top Applicants
- MolecuLight, Inc. — 1 clearance
