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) → NUU — Lens, Contact, Orthokeratology, Overnight

# NUU · Lens, Contact, Orthokeratology, Overnight

_Ophthalmic · 21 CFR 886.5916 · Class 3_

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

## Overview

- **Product Code:** NUU
- **Device Name:** Lens, Contact, Orthokeratology, Overnight
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240045](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NUU/P240045.md) | Optimum Infinite (tisilfocon A) Orthokeratology Lenses II | Contamac, Ltd. | Feb 10, 2026 | APPR |
| [P050031](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NUU/P050031.md) | PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY | CooperVision, Inc. | Nov 16, 2006 | APPR |
| [P040029](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NUU/P040029.md) | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact | Euclid Vision Corporation | Sep 29, 2004 | APPR |
| [P010062](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NUU/P010062.md) | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR | Bausch & Lomb | Jun 7, 2004 | APPR |

## Top Applicants

- Bausch & Lomb — 1 clearance
- Contamac, Ltd. — 1 clearance
- CooperVision, Inc. — 1 clearance
- Euclid Vision Corporation — 1 clearance

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

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