§ 884.6200. Assisted reproduction laser system.
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/us/cfr/t21/s§ 884.6200·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 884.6200
Assisted reproduction laser system.
Fed. Reg.×1
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