Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 886  /  Sec. 886.4270 Intraocular gas.

(a) Identification. An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See Sec. 886.3.