21 C.F.R. § 884.6200 Assisted reproduction laser system.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart G—Assisted Reproduction Devices
§ 884.6200 Assisted reproduction laser system.
