21 C.F.R. § 886.3130 Ophthalmic conformer.
Title 21 - Food and Drugs
(a) Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ] (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9. [52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart D—Prosthetic Devices
§ 886.3130 Ophthalmic conformer.
