EYE ARTIFICIAL CUSTOM
Device Facts
| Record ID | K904962 |
|---|---|
| Device Name | EYE ARTIFICIAL CUSTOM |
| Applicant | Midwest Eye Laboratories, Inc. |
| Product Code | HQH · Ophthalmic |
| Decision Date | Aug 30, 1991 |
| 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.
