Shell, Scleral
A Scleral Shell is a thin, curved prosthetic device placed over a blind or disfigured eye beneath the eyelids to restore the cosmetic appearance of a natural eye, used when the globe is present but visually non-functional. This device is FDA Class 2 (moderate risk), subject to general controls and special controls. It carries product code HQT and is regulated under 21 CFR 886.3800, within the Ophthalmic medical specialty. It is classified as an implant.
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Basic Information
- Product Code
- HQT
- Device Class
- FDA class 2
- Regulation Number
- 886.3800
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K970327 | SCLERAL SHELL | Jul 07, 1997 | Substantially Equivalent | Southwest Artificial Eyes, Inc. |
| K970320 | SCLERAL SHELL | Jul 07, 1997 | Substantially Equivalent | Xavier A. Guerra, Ocularist, Inc. |
| K904961 | ARTIFICIAL SCLERAL SHELL | Aug 30, 1991 | Substantially Equivalent | Midwest Eye Laboratories, Inc. |
| K855105 | SIMMONS SHELL | Mar 31, 1986 | Substantially Equivalent | Mira, Inc. |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.