← Product Code [HJH](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH) · K874845

# MALIS SURGICAL LOUPES (K874845)

_Valley Forge Scientific Corp. · HJH · Dec 23, 1987 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH/K874845

## Device Facts

- **Applicant:** Valley Forge Scientific Corp.
- **Product Code:** [HJH](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH.md)
- **Decision Date:** Dec 23, 1987
- **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/K874845](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJH/K874845)

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