21 CFR § 886.4270 Ophthalmic Devices

§ 886.4270 Intraocular gas.

Current through Sep 8, 2026 · Read all of Part 886

(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.

← § 886.4250 Ophthalmic electrolysis unit.§ 886.4275 Intraocular fluid. →