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52 FR 33355, Sept. 2, 1987, unless otherwise noted.
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Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9, if the device is made from the same materials, has the same chemical composition, and uses the same manufacturing processes as currently legally marketed devices.
[61 FR 1124, Jan. 16, 1996, as amended at 66 FR 38813, July 25, 2001]