Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1450](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1450) → HJB — Instrument, Measuring, Corneal Radius

# HJB · Instrument, Measuring, Corneal Radius

_Ophthalmic · 21 CFR 886.1450 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB

## Overview

- **Product Code:** HJB
- **Device Name:** Instrument, Measuring, Corneal Radius
- **Regulation:** [21 CFR 886.1450](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1450)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.

## 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, only when the device does not include computer software in the unit or topographers.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K930444](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K930444.md) | MARCO STANDARD KERATOMETERS | Marco Ophthalmic, Inc. | Aug 9, 1993 | SESE |
| [K924779](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K924779.md) | BURTON KERATOMETER - MODLE 2040 | R.H. Burton Co. | Apr 5, 1993 | SESE |
| [K864369](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K864369.md) | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER | Heidelberg Instruments | Dec 15, 1986 | SESE |
| [K864037](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K864037.md) | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER | Kera Corp. | Nov 13, 1986 | SESE |
| [K852424](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB/K852424.md) | ACUFEX COMPARATIVE SURGICAL KERATOMETER | Acufex Microsurgical, Inc. | Sep 11, 1985 | SESE |

## Top Applicants

- R.H. Burton Co. — 1 clearance
- Marco Ophthalmic, Inc. — 1 clearance
- Kera Corp. — 1 clearance
- Heidelberg Instruments — 1 clearance
- Acufex Microsurgical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJB)

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