Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4070](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4070) → HQS — Burr, Corneal, Ac-Powered

# HQS · Burr, Corneal, Ac-Powered

_Ophthalmic · 21 CFR 886.4070 · Class 1_

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

## Overview

- **Product Code:** HQS
- **Device Name:** Burr, Corneal, Ac-Powered
- **Regulation:** [21 CFR 886.4070](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4070)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K971078](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQS/K971078.md) | HYDROBRUSH (TM) KERATOME | Medjet, Inc. | Jan 23, 1998 | SESE |

## Top Applicants

- Medjet, Inc. — 1 clearance

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

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