← Product Code [HPJ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ) · K864012

# IRAS PERIMETER (K864012)

_Randwal Instrument Co., Inc. · HPJ · Dec 12, 1986 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K864012

## Device Facts

- **Applicant:** Randwal Instrument Co., Inc.
- **Product Code:** [HPJ](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ.md)
- **Decision Date:** Dec 12, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1360
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K864012](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPJ/K864012)

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