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) → PUE — Biomicroscope, Slit-Lamp, Ac-Powered, Exempt

# PUE · Biomicroscope, Slit-Lamp, Ac-Powered, Exempt

_Ophthalmic · 21 CFR 886.1850 · Class 2_

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

## Overview

- **Product Code:** PUE
- **Device Name:** Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
- **Regulation:** [21 CFR 886.1850](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1850)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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 (0 of 0)

_No cleared devices on record._

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

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