{"data":{"id":"us/21-cfr-886.1945","jurisdiction":"us","citation":"21 CFR 886.1945","heading":"Transilluminator.","body":"(a) Identification. A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.\n(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.\n(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 886—OPHTHALMIC DEVICES","Subpart B—Diagnostic 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":"ae3a3ae8cbb5f0e15e2592ed41efa6fd33258f2d8be51d19292e9379b7e03560","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-886.1940","next":"us/21-cfr-886.3100"},"notice":"GroundRules: Original legal text. Not legal advice."}