21 C.F.R. § 886.3340 Extraocular orbital implant.
Title 21 - Food and Drugs
(a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded. (b) Classification. Class II.
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart D—Prosthetic Devices
§ 886.3340 Extraocular orbital implant.
