Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300) → NCE — Injector, Capsular Tension Ring

# NCE · Injector, Capsular Tension Ring

_Ophthalmic · 21 CFR 886.4300 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCE

## Overview

- **Product Code:** NCE
- **Device Name:** Injector, Capsular Tension Ring
- **Regulation:** [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

## Classification Rationale

Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K042478](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCE/K042478.md) | CAPSULE TENSION RING INSERTER, MODEL 7-810 | Duckworth & Kent, Ltd. | Dec 28, 2004 | SESE |
| [K011498](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCE/K011498.md) | EASY CONTROL MICRO INSERTER, MODEL ON385 | Ophtec USA, Inc. | Jul 9, 2001 | SESE |
| [K001125](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCE/K001125.md) | GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING | Geuder GmbH | Oct 4, 2000 | SESE |

## Top Applicants

- Duckworth & Kent, Ltd. — 1 clearance
- Geuder GmbH — 1 clearance
- Ophtec USA, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCE](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/NCE)

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