21 CFR 886.3130
§ 886.3130 Ophthalmic conformer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.3130, § 886.3130 Ophthalmic conformer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90963
- Permanent ID
ys:prov:90963@1- SHA-256
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Full text
(a) Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]
(b) Classification. Class II (special controls). 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.