{"data":{"id":"us/21-cfr-886.4570","jurisdiction":"us","citation":"21 CFR 886.4570","heading":"Ophthalmic surgical marker.","body":"(a) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.\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 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":"3a206febf79e8557d0308608dcea76f51b1f66fa393ad3d228ac9d94631ac88e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-886.4445","next":"us/21-cfr-886.4610"},"notice":"GroundRules: Original legal text. Not legal advice."}