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) → HRG — Engine, Trephine, Accessories, Ac-Powered

# HRG · Engine, Trephine, Accessories, Ac-Powered

_Ophthalmic · 21 CFR 886.4070 · Class 1_

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

## Overview

- **Product Code:** HRG
- **Device Name:** Engine, Trephine, Accessories, 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K013151](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K013151.md) | ASMOTOM AUTOMATED TREPHINE SYSTEM | Bkg Opthalmics USA, Inc. | Dec 14, 2001 | SESE |
| [K981063](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K981063.md) | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | Jun 23, 1998 | SESE |
| [K843957](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K843957.md) | ULTRATHIN/SP LENS | Optical Systems Intl., Inc. | Jul 31, 1985 | SESE |
| [K841515](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K841515.md) | SCANLAN VASCU-STATT II | Scanlan Intl., Inc. | Jun 5, 1984 | SESE |
| [K823901](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K823901.md) | TREPHINE BLADES-VARIOUS MODELS | Edward Weck, Inc. | Jan 17, 1983 | SESE |
| [K791763](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HRG/K791763.md) | (MICRO-KERATRON, MICRO DUCT TREPHINE) | Intl. Ophthalmic Industries Corp. | Nov 5, 1979 | SESE |

## Top Applicants

- Scanlan Intl., Inc. — 1 clearance
- Optical Systems Intl., Inc. — 1 clearance
- Laser Center Dev. Corp. — 1 clearance
- Intl. Ophthalmic Industries Corp. — 1 clearance
- Edward Weck, Inc. — 1 clearance

---

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

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