CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 886—OPHTHALMIC DEVICES > SUBPART E—Surgical Devices (§886.4070 to §886.4855) > 886.4270—Intraocular gas.

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.