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.
Device Type ID | 5907 |
Device Name | Wound Autofluorescence Imaging Device |
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 |
Submission Type | 510(k) |
CFR Regulation Number | 878.4165 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | QCR |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |