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§ 886.3600 Intraocular lens.

21 CFR 886.3600

Citation21 CFR 886.3600
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 886.3600 Intraocular lens.

(a) Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.