Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5916](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5916) → MWL — Lens, Contact (Rigid Gas Permeable), Extended Wear

# MWL · Lens, Contact (Rigid Gas Permeable), Extended Wear

_Ophthalmic · 21 CFR 886.5916 · Class 3_

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

## Overview

- **Product Code:** MWL
- **Device Name:** Lens, Contact (Rigid Gas Permeable), Extended Wear
- **Regulation:** [21 CFR 886.5916](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5916)
- **Device Class:** 3
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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.

## Classification Rationale

(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P990018](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MWL/P990018.md) | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | Jul 11, 2000 | APPR |
| [P880098](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MWL/P880098.md) | MENICON SF-P RGP (MELAFOCON A) CONTACT LENS | Menicon Co, Ltd. | Sep 1, 1989 | APWD |
| [P890020](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MWL/P890020.md) | FLUOROCON TM-60 | Ciba Vision Corporation | Jun 23, 1989 | APWD |
| [P870024](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MWL/P870024.md) | FLUOROPERM RGP CONTACT LENSES | CooperVision, Inc. | Dec 31, 1987 | APPR |
| [P860022](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MWL/P860022.md) | BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Bausch & Lomb | Nov 30, 1987 | APPR |
| [P850038](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MWL/P850038.md) | PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN | Paragon Optical Co. | Dec 31, 1986 | APWD |

## Top Applicants

- Menicon Co, Ltd. — 2 clearances
- Bausch & Lomb — 1 clearance
- Ciba Vision Corporation — 1 clearance
- CooperVision, Inc. — 1 clearance
- Paragon Optical Co. — 1 clearance

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

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