21 C.F.R. § 886.4270

Current through October 31, 2024
Section 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 § 886.3 .

21 C.F.R. §886.4270