---
kind: "section"
citation: "21 C.F.R. § 886.4355"
title: "21"
number: "886.4355"
heading: "Corneal inlay inserter handle."
url: "https://uscodex.org/cfr/21/886.4355"
---

# §886.4355. Corneal inlay inserter handle.

- (a) **Identification.** The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
- (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

[84 FR 14870, Apr. 12, 2019]

### 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

[84 FR 14870, Apr. 12, 2019]