{"data":{"id":"us/21-cfr-886.1050","jurisdiction":"us","citation":"21 CFR 886.1050","heading":"Adaptometer (biophotometer).","body":"(a) Identification. An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.\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 § 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":"62ca897740747547ac41b7790dd8294d8ed8a749b13f98cfe50e6a18294302f2","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-886.1040","next":"us/21-cfr-886.1070"},"notice":"GroundRules: Original legal text. Not legal advice."}
