← Product Code [FXF](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXF) · K801058

# ILLUMINATED SPECULUM (K801058)

_Designs For Vision, Inc. · FXF · May 28, 1980 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXF/K801058

## Device Facts

- **Applicant:** Designs For Vision, Inc.
- **Product Code:** [FXF](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXF.md)
- **Decision Date:** May 28, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.1800
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXF/K801058](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/FXF/K801058)

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