Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1330](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1330) → QTW — Digital Amsler Grid

# QTW · Digital Amsler Grid

_Ophthalmic · 21 CFR 886.1330 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTW

## Overview

- **Product Code:** QTW
- **Device Name:** Digital Amsler Grid
- **Regulation:** [21 CFR 886.1330](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1330)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

## 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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K203594](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTW/K203594.md) | EyeCTester | Neuro-Eye Diagnostic Systems, LLC | Sep 7, 2022 | SESE |

## Top Applicants

- Neuro-Eye Diagnostic Systems, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTW](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QTW)

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