---
kind: "section"
citation: "21 C.F.R. § 886.3800"
title: "21"
number: "886.3800"
heading: "Scleral shell."
url: "https://uscodex.org/cfr/21/886.3800"
---

# §886.3800. Scleral shell.

- (a) **Identification.** A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.
- (b) **Classification.** Class II (special 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 [§ 886.9](/cfr/21/886.9.md).

## Notes

### Amendments

[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]

### 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 63 FR 59230, Nov. 3, 1998]