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) → MUW — Lens, Contact (Orthokeratology)

# MUW · Lens, Contact (Orthokeratology)

_Ophthalmic · 21 CFR 886.5916 · Class 2_

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

## Overview

- **Product Code:** MUW
- **Device Name:** Lens, Contact (Orthokeratology)
- **Regulation:** [21 CFR 886.5916](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5916)
- **Device Class:** 2
- **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 |
| --- | --- | --- | --- | --- |
| [K183200](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MUW/K183200.md) | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses | C&E GP Specialist, Inc. | Jan 9, 2019 | SESE |
| [K160859](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MUW/K160859.md) | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Contamac, Ltd. | Jul 13, 2016 | SESE |
| [K010109](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MUW/K010109.md) | FLUOROPERM 151-OK, PARAGON HDS 100-OK | Paragon Vision Sciences | Feb 28, 2001 | SESU |
| [K003933](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MUW/K003933.md) | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | Polymer Technology | Feb 16, 2001 | SESE |
| [K000224](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MUW/K000224.md) | FLUROPERM 60-OK, PARAGON HDS-OK | Paragon Vision Sciences | Apr 17, 2000 | SESU |
| [K973697](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MUW/K973697.md) | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY | Airperm, Inc. | Apr 8, 1998 | SESE |

## Top Applicants

- Paragon Vision Sciences — 2 clearances
- Airperm, Inc. — 1 clearance
- C&E GP Specialist, Inc. — 1 clearance
- Contamac, Ltd. — 1 clearance
- Polymer Technology — 1 clearance

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

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