21 CFR 886.3200 — Eye, Artificial, Non-Custom
Ophthalmic (OP) · Part 886 Subpart D—Prosthetic Devices · § 886.3200
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQH | Eye, Artificial, Non-Custom | 1 | 6 | |
| NCK | Button, Iris, Eye, Artificial | 1 | 1 |
