{"data":{"id":"us/21-cfr-878.4165","jurisdiction":"us","citation":"21 CFR 878.4165","heading":"Wound autofluorescence imaging device.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"7a6cb9da87c4f4d657be84c0109f17aeef1b06d378603de5d031372f5d007117","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4160","next":"us/21-cfr-878.4200"},"notice":"GroundRules: Original legal text. Not legal advice."}