CUSTOM OCULAR PROSTHESIS
Device Facts
| Record ID | K946226 |
|---|---|
| Device Name | CUSTOM OCULAR PROSTHESIS |
| Applicant | Frank Tanaka, Ocularist, Inc. |
| Product Code | HQH · Ophthalmic |
| Decision Date | Mar 22, 1995 |
| 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.
