(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]