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U.S. Department of Health and Human Services

Product Classification

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Device wound autofluorescence imaging device
Regulation Description Wound autofluorescence imaging device.
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.
Physical State The device has a non-contact housing that emits non-coherent excitation light in visible spectrum and captures fluorescence image of the target materials/tissues. No imaging contrast agent are required for autofluorescence imaging.
Technical Method The imaging device is non-contact medical device and captures autofluorescence images using non-coherent excitation light source in visible spectrum.
Target Area Wounds through the skin.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQCR
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4165
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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