21 C.F.R. § 878.4165

Current through September 30, 2024
Section 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 .

21 C.F.R. §878.4165

83 FR 52968, Oct. 19, 2018
83 FR 52968, 10/19/2018