← Product Code [HJH](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH) · K863983

# EXETER OPERATING LOUPE (K863983)

_Exeter Instruments, Inc. · HJH · Nov 10, 1986 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH/K863983

## Device Facts

- **Applicant:** Exeter Instruments, Inc.
- **Product Code:** [HJH](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH.md)
- **Decision Date:** Nov 10, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5120
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH/K863983](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH/K863983)

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