{"data":{"id":"us/21-cfr-878.4580","jurisdiction":"us","citation":"21 CFR 878.4580","heading":"Surgical lamp.","body":"(a) Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.\n(b) Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, 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":"dedbc2c1891d60c5628a8e0fb56436fc0fd434d836e77613e38e5fd2836f262f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4550","next":"us/21-cfr-878.4590"},"notice":"GroundRules: Original legal text. Not legal advice."}