---
kind: "section"
citation: "21 C.F.R. § 884.6200"
title: "21"
number: "884.6200"
heading: "Assisted reproduction laser system."
url: "https://uscodex.org/cfr/21/884.6200"
---

# §884.6200. Assisted reproduction laser system.

- (a) **Identification.** The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.
- (b) **Classification.** Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See [§ 884.1(e)](/cfr/21/884.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[69 FR 77624, Dec. 28, 2004]

### Source

Source: 63 FR 48436, Sept. 10, 1998, unless otherwise noted.

### Authority

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

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

[69 FR 77624, Dec. 28, 2004]