21 CFR 884.6200
§ 884.6200 Assisted reproduction laser system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.6200, § 884.6200 Assisted reproduction laser system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90883
- Permanent ID
ys:prov:90883@1- SHA-256
8e4720ef9dd69bb5560ab148ee359dad0b59780ae4b8b4cfa8588f744266376f
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.