21 CFR § 878.4165
Wound autofluorescence imaging device
June 25, 2020
(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.
[83 FR 52968, Oct. 19, 2018]
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