Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1850](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1850) → NQE — Microscope, Specular

# NQE · Microscope, Specular

_Ophthalmic · 21 CFR 886.1850 · Class 2_

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

## Overview

- **Product Code:** NQE
- **Device Name:** Microscope, Specular
- **Regulation:** [21 CFR 886.1850](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1850)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

## Classification Rationale

Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, 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 intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, 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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K191558](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K191558.md) | Konan Specular Microscope XVII | Konan Medical, Inc. | Mar 26, 2020 | SESE |
| [K173980](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K173980.md) | Specular Microscope CEM-530 | Nidek Co., Ltd. | Mar 14, 2018 | SESE |
| [K171313](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K171313.md) | EM-4000 Specular Microscope | Tomey Corporation | Jan 19, 2018 | SESE |
| [K151706](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K151706.md) | Specular Microscope CEM- 530 | Nidek Co., Ltd. | Mar 17, 2016 | SESE |
| [K142417](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K142417.md) | SP-1PSpecular Microscope | Topcon Corporation | May 29, 2015 | SESE |
| [K130565](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K130565.md) | SPECULAR MICROSCOPE CEM-530 | Nidek Co., Ltd. | Nov 27, 2013 | SESE |
| [K120264](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K120264.md) | KONAN SPECULAR MICROSCOPE XIV | Konan Medical, Inc. | Apr 11, 2012 | SESE |
| [K062763](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K062763.md) | NONCON ROBO PACHY F&A | Konan Medical, Inc. | Feb 22, 2008 | SESE |
| [K040373](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/NQE/K040373.md) | KERATO ANALYZER (EKA) | Konan Medical, Inc. | Mar 19, 2004 | SESE |

## Top Applicants

- Konan Medical, Inc. — 4 clearances
- Nidek Co., Ltd. — 3 clearances
- Tomey Corporation — 1 clearance
- Topcon Corporation — 1 clearance

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

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