Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5820](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5820) → HJG — System, Reading, Television, Closed-Circuit

# HJG · System, Reading, Television, Closed-Circuit

_Ophthalmic · 21 CFR 886.5820 · Class 1_

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

## Overview

- **Product Code:** HJG
- **Device Name:** System, Reading, Television, Closed-Circuit
- **Regulation:** [21 CFR 886.5820](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5820)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material.

## 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 § 886.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K933633](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K933633.md) | LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE | Gracefully Yours, Inc. | Feb 22, 1994 | SESE |
| [K915340](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K915340.md) | MENTOR HORIZON LOW VISION MAGNIFIER | Mentor O & O, Inc. | Mar 30, 1992 | SESE |
| [K920069](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K920069.md) | MAGNI-CAM | Innoventions, Inc. | Mar 2, 1992 | SESE |
| [K892351](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K892351.md) | MAGNILINK SYSTEM 602 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| [K892350](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K892350.md) | MAGNILINK SYSTEM 402/5 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| [K892349](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K892349.md) | MAGNILINK SYSTEM 209 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| [K892348](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K892348.md) | MAGNILINK SYSTEM 201 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |
| [K892347](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HJG/K892347.md) | MAGNILINK SYSTEM 101 | Coburn Optical Ind., Inc. | May 26, 1989 | SESE |

## Top Applicants

- Coburn Optical Ind., Inc. — 5 clearances
- Gracefully Yours, Inc. — 1 clearance
- Innoventions, Inc. — 1 clearance
- Mentor O & O, Inc. — 1 clearance

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

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