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e-CFR data is current as of January 14, 2021

Title 21Chapter ISubchapter HPart 878Subpart E → §878.4165


Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices


§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.

[83 FR 52968, Oct. 19, 2018]

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