NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
Device Facts
| Record ID | K001326 |
|---|---|
| Device Name | NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON |
| Applicant | Ocular Concepts, LLC |
| Product Code | NCK · Ophthalmic |
| Decision Date | Jun 13, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3200 |
| Device Class | Class 1 |
Regulatory Classification
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.
