21 CFR 886.4570
§ 886.4570 Ophthalmic surgical marker.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.4570, § 886.4570 Ophthalmic surgical marker, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90996
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Full text
(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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.