Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1360](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1360) → HPJ — Instrument, Visual Field, Laser

# HPJ · Instrument, Visual Field, Laser

_Ophthalmic · 21 CFR 886.1360 · Class 2_

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

## Overview

- **Product Code:** HPJ
- **Device Name:** Instrument, Visual Field, Laser
- **Regulation:** [21 CFR 886.1360](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1360)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A visual field laser instrument is an AC-powered device intended to provide visible laser radiation that produces an interference pattern on the retina to evaluate retinal function.

## Classification Rationale

Class II.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K864012](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K864012.md) | IRAS PERIMETER | Randwal Instrument Co., Inc. | Dec 12, 1986 | SESE |
| [K853556](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K853556.md) | LASER IRAS | Randwal Instrument Co., Inc. | Nov 1, 1985 | SESE |
| [K822415](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K822415.md) | THE OCUPLOT D | Coherent Medical Division | Sep 7, 1982 | SESE |
| [K813429](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K813429.md) | LASER PHOTOCOAGULATOR ARGON MED. LASER | American Laser Corp. | Jan 22, 1982 | SESE |
| [K781507](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K781507.md) | RETINOMETER | Coburn Optical Ind., Inc. | Nov 15, 1978 | SESE |

## Top Applicants

- Randwal Instrument Co., Inc. — 2 clearances
- American Laser Corp. — 1 clearance
- Coburn Optical Ind., Inc. — 1 clearance
- Coherent Medical Division — 1 clearance

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

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