{"data":{"id":"us/21-cfr-886.1450","jurisdiction":"us","citation":"21 CFR 886.1450","heading":"Corneal radius measuring device.","body":"(a) Identification. A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.\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, only when the device does not include computer software in the unit or topographers.","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":"77ddaa5b9799a861c6c62d7441782e15d3d3dc9bb0026d6fa70326efacfc36b5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-886.1435","next":"us/21-cfr-886.1460"},"notice":"GroundRules: Original legal text. Not legal advice."}