Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1040](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1040) → HJC — Esthesiometer, Ocular

# HJC · Esthesiometer, Ocular

_Ophthalmic · 21 CFR 886.1040 · Class 1_

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

## Overview

- **Product Code:** HJC
- **Device Name:** Esthesiometer, Ocular
- **Regulation:** [21 CFR 886.1040](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1040)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K920271](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJC/K920271.md) | WEINSTEIN CORNEAL MIRCOAESTHESIOMETER | Connecticut Bioinstruments, Inc. | Apr 21, 1992 | SESE |
| [K851557](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HJC/K851557.md) | ANESTHESIOMETER | Luneau SA | May 30, 1985 | SESE |

## Top Applicants

- Luneau SA — 1 clearance
- Connecticut Bioinstruments, Inc. — 1 clearance

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

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