21 CFR 886.4300
§ 886.4300 Intraocular lens guide.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.4300, § 886.4300 Intraocular lens guide, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90984
- Permanent ID
ys:prov:90984@1- SHA-256
133456397e4ffd0278640c7380cd7f4b756ed57300e11aa37fac143c44d13609
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Full text
(a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
(b) Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 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.