21 CFR 886.1040

§ 886.1040 Ocular esthesiometer.

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

Cite this

Citation: 21 CFR 886.1040, § 886.1040 Ocular esthesiometer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90890
Permanent ID: ys:prov:90890@1
SHA-256: b2c4e5bec4b80ecfcd4015887657f2050044d141a2a682dbbba28932c97eedbc

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Full text

(a) Identification. An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity. (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.