Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5840](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5840) → HOI — Spectacle, Magnifying

# HOI · Spectacle, Magnifying

_Ophthalmic · 21 CFR 886.5840 · Class 1_

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

## Overview

- **Product Code:** HOI
- **Device Name:** Spectacle, Magnifying
- **Regulation:** [21 CFR 886.5840](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5840)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 866.9.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K943613](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K943613.md) | NIL | Sing Wah International Enterprises , Ltd. | Sep 21, 1994 | SESE |
| [K930435](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K930435.md) | SPECTACLE FRAMES | Venis DI A. Vendrame | Sep 20, 1993 | SESE |
| [K931328](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K931328.md) | PYRAMID SUNGLASSES/PYRAMID READING GLASSES | Pyramid | Aug 10, 1993 | SESE |
| [K910329](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K910329.md) | SUNGLASSES | Cutler & Gross Sloan Optical , Ltd. | Mar 12, 1991 | SESE |
| [K854854](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K854854.md) | SYSTEMS OF SIGHT LOW VISION EYEWARE | Int'L Eye Care, Inc. | Feb 4, 1986 | SESE |
| [K844716](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K844716.md) | MAGNIFYING SPECTACLES W/PLASTIC LENSES | Gazelle Corp. | Jan 3, 1985 | SESE |
| [K844038](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K844038.md) | VISITEC MAGNIFYING SPECTACLES | Visitec Co. | Nov 29, 1984 | SESE |
| [K842835](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K842835.md) | BRILLETTE MODEL | Cillus Company, Inc. | Nov 21, 1984 | SESE |
| [K820732](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K820732.md) | LA VEL LATERAL VIEW EXTENSION LENS | Peter M. Tolliver | May 3, 1982 | SESE |
| [K813548](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K813548.md) | UVEX MINI-SPECS | Bacou USA, Inc. and Uvex Safety, Inc. | Mar 2, 1982 | SESE |
| [K801733](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K801733.md) | FENZL RETICLE | Robert E. Fenzl, M.D. | Sep 16, 1980 | SESE |

## Top Applicants

- Bacou USA, Inc. and Uvex Safety, Inc. — 1 clearance
- Cillus Company, Inc. — 1 clearance
- Cutler & Gross Sloan Optical , Ltd. — 1 clearance
- Gazelle Corp. — 1 clearance
- Int'L Eye Care, Inc. — 1 clearance

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

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