← Product Code [HKC](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HKC) · K830774

# BINOCULAR MAGNIFIER 2X (K830774)

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

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HKC/K830774

## Device Facts

- **Applicant:** Almore Intl., Inc.
- **Product Code:** [HKC](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HKC.md)
- **Decision Date:** Apr 6, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5540
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HKC/K830774](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HKC/K830774)

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