← Product Code [HJH](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH) · K830878

# BINOCULAR LOUPE (K830878)

_Almore Intl., Inc. · HJH · Apr 6, 1983 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH/K830878

## Device Facts

- **Applicant:** Almore Intl., Inc.
- **Product Code:** [HJH](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH.md)
- **Decision Date:** Apr 6, 1983
- **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/K830878](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH/K830878)

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