← Product Code [HQD](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD) · K952260

# OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) (K952260)

_Stellar Contact Lens, Inc. · HQD · Jan 3, 1996 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K952260

## Device Facts

- **Applicant:** Stellar Contact Lens, Inc.
- **Product Code:** [HQD](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD.md)
- **Decision Date:** Jan 3, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5916
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K952260](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K952260)

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