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) → QQQ — Guide And Positioner, Ophthalmic Drug Delivery Device

# QQQ · Guide And Positioner, Ophthalmic Drug Delivery Device

_Ophthalmic · 21 CFR 886.4300 · Class 1_

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

## Overview

- **Product Code:** QQQ
- **Device Name:** Guide And Positioner, Ophthalmic Drug Delivery Device
- **Regulation:** [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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 (0 of 0)

_No cleared devices on record._

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

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