21 CFR § 884.6200 - Assisted reproduction laser system.

---
identifier: "/us/cfr/t21/s884.6200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.6200 - Assisted reproduction laser system."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.6200"
section_name: "Assisted reproduction laser system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 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) for the availability of this guidance document.

[69 FR 77624, Dec. 28, 2004]