Title 21: Food and Drugs
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/ PART 878 - GENERAL AND PLASTIC SURGERY DEVICES
/ Subpart E - Surgical Devices / § 878.4165 Wound autofluorescence imaging device.
§ 878.4165 Wound autofluorescence imaging device.
(a) 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.
(b) Classification. 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.