HQT · Shell, Scleral
Ophthalmic · 21 CFR 886.3800 · Class 2
Overview
| Product Code | HQT |
|---|---|
| Device Name | Shell, Scleral |
| Regulation | 21 CFR 886.3800 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970327 | SCLERAL SHELL | Southwest Artificial Eyes, Inc. | Jul 7, 1997 | SESE |
| K970320 | SCLERAL SHELL | Xavier A. Guerra, Ocularist, Inc. | Jul 7, 1997 | SESE |
| K904961 | ARTIFICIAL SCLERAL SHELL | Midwest Eye Laboratories, Inc. | Aug 30, 1991 | SESE |
| K855105 | SIMMONS SHELL | Mira, Inc. | Mar 31, 1986 | SESE |
Top Applicants
- Midwest Eye Laboratories, Inc. — 1 clearance
- Mira, Inc. — 1 clearance
- Southwest Artificial Eyes, Inc. — 1 clearance
- Xavier A. Guerra, Ocularist, Inc. — 1 clearance
