---
kind: "section"
citation: "21 C.F.R. § 886.1405"
title: "21"
number: "886.1405"
heading: "Ophthalmic trial lens set."
url: "https://uscodex.org/cfr/21/886.1405"
---

# §886.1405. Ophthalmic trial lens set.

- (a) **Identification.** An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.
- (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 61 FR 1124, Jan. 16, 1996; 66 FR 38811, 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 61 FR 1124, Jan. 16, 1996; 66 FR 38811, July 25, 2001]