← Product Code [HQD](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD) · K010454

# THE ALBERTA LENS SM2, SULFOCON B (K010454)

_Progressive Optical Research , Ltd. · HQD · Aug 1, 2001 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K010454

## Device Facts

- **Applicant:** Progressive Optical Research , Ltd.
- **Product Code:** [HQD](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD.md)
- **Decision Date:** Aug 1, 2001
- **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/K010454](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQD/K010454)

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