ARTIFICIAL SCLERAL SHELL
Device Facts
| Record ID | K904961 |
|---|---|
| Device Name | ARTIFICIAL SCLERAL SHELL |
| Applicant | Midwest Eye Laboratories, Inc. |
| Product Code | HQT · Ophthalmic |
| Decision Date | Aug 30, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
