eCFR Reference Browser

---

title: "21 CFR §878.4165"

source: "https://www.ecfr.gov/current/title-21/section-878.4165"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "878"

part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"

subpart_code: "E"

subpart_subject: "Surgical Devices"

section_number: "878.4165"

section_subject: "Wound autofluorescence imaging device."

cfr_reference: "21 CFR 878.4165"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§878.4165 - Wound autofluorescence imaging device.