21 CFR 886.5840

§ 886.5840 Magnifying spectacles.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 886.5840, § 886.5840 Magnifying spectacles, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91022
Permanent ID: ys:prov:91022@1
SHA-256: aac04fd53d77b2e86846087101b5c09a17198e9ba50215fa2d6e81891954dcfa

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Full text

(a) Identification. Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images. (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 § 866.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.