Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4355](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4355) → QGJ — Corneal Inlay Inserter Handle

# QGJ · Corneal Inlay Inserter Handle

_Ophthalmic · 21 CFR 886.4355 · Class 1_

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

## Overview

- **Product Code:** QGJ
- **Device Name:** Corneal Inlay Inserter Handle
- **Regulation:** [21 CFR 886.4355](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4355)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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/QGJ](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/QGJ)

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