Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart B — Diagnostic Devices](/submissions/SU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 878.1800](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1800) → FXF — Speculum, Illuminated

# FXF · Speculum, Illuminated

_General, Plastic Surgery · 21 CFR 878.1800 · Class 1_

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

## Overview

- **Product Code:** FXF
- **Device Name:** Speculum, Illuminated
- **Regulation:** [21 CFR 878.1800](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1800)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

## 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 § 878.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K801058](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXF/K801058.md) | ILLUMINATED SPECULUM | Designs For Vision, Inc. | May 28, 1980 | SESE |

## Top Applicants

- Designs For Vision, Inc. — 1 clearance

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

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