---
kind: "section"
citation: "21 C.F.R. § 886.1040"
title: "21"
number: "886.1040"
heading: "Ocular esthesiometer."
url: "https://uscodex.org/cfr/21/886.1040"
---

# §886.1040. Ocular esthesiometer.

- (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](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 886.9](/cfr/21/886.9.md).

## Notes

### Amendments

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, 2001]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

### Amendments

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, 2001]