NCK · Button, Iris, Eye, Artificial
Ophthalmic · 21 CFR 886.3200 · Class 1
Overview
| Product Code | NCK |
|---|---|
| Device Name | Button, Iris, Eye, Artificial |
| Regulation | 21 CFR 886.3200 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001326 | NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON | Ocular Concepts, LLC | Jun 13, 2000 | SESE |
Top Applicants
- Ocular Concepts, LLC — 1 clearance
