(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 (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]