21 C.F.R. § 886.3320 Eye sphere implant.
Title 21 - Food and Drugs
(a) Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. (b) Classification. Class II.
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart D—Prosthetic Devices
§ 886.3320 Eye sphere implant.