HQH · Eye, Artificial, Non-Custom
Ophthalmic · 21 CFR 886.3200 · Class 1
Overview
| Product Code | HQH |
|---|---|
| Device Name | Eye, Artificial, Non-Custom |
| 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952538 | ROBERT B. SCOTT PLASTIC ARTIFICAL | Robert B. Scott Ocularists of Florida, Inc. | Jun 26, 1995 | SESE |
| K945270 | CUSTOM ARTIFICIAL HUMAN EYES | Daniel T Acosta | May 30, 1995 | SESE |
| K946226 | CUSTOM OCULAR PROSTHESIS | Frank Tanaka, Ocularist, Inc. | Mar 22, 1995 | SESE |
| K923167 | THE NISSEL ARTIFICIAL EYE | Nissel , Ltd. | Sep 2, 1992 | SESE |
| K904962 | EYE ARTIFICIAL CUSTOM | Midwest Eye Laboratories, Inc. | Aug 30, 1991 | SESE |
| K791923 | SCLERAL POWDER | Ocularists , Ltd. | Jan 10, 1980 | SESE |
Top Applicants
- Daniel T Acosta — 1 clearance
- Frank Tanaka, Ocularist, Inc. — 1 clearance
- Midwest Eye Laboratories, Inc. — 1 clearance
- Nissel , Ltd. — 1 clearance
- Ocularists , Ltd. — 1 clearance
