Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1120](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1120) → QER — Camera, Ophthalmic, Slit-Scanning

# QER · Camera, Ophthalmic, Slit-Scanning

_Ophthalmic · 21 CFR 886.1120 · Class 2_

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

## Overview

- **Product Code:** QER
- **Device Name:** Camera, Ophthalmic, Slit-Scanning
- **Regulation:** [21 CFR 886.1120](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1120)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

## Classification Rationale

Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243878](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QER/K243878.md) | CLARUS (700) | Carl Zeiss Meditec, Inc. | Apr 17, 2025 | SESE |
| [K191194](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QER/K191194.md) | CLARUS | Carl Zeiss Meditec, Inc. | Jun 25, 2019 | SESE |
| [K181444](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/QER/K181444.md) | CLARUS | Carl Zeiss Meditec, Inc. | Jan 10, 2019 | SESE |

## Top Applicants

- Carl Zeiss Meditec, Inc. — 3 clearances

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

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