Title 21

SECTION 886.3200

886.3200 Artificial eye.

§ 886.3200 Artificial eye.

(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]

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