← Product Code [HQT](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT) · K904961

# ARTIFICIAL SCLERAL SHELL (K904961)

_Midwest Eye Laboratories, Inc. · HQT · Aug 30, 1991 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT/K904961

## Device Facts

- **Applicant:** Midwest Eye Laboratories, Inc.
- **Product Code:** [HQT](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT.md)
- **Decision Date:** Aug 30, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3800
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT/K904961](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT/K904961)

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