← Product Code [LLW](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LLW) · K850437

# DISPOSABLE LARYNGOSCOPE (K850437)

_Vital Signs, Inc. · LLW · Feb 14, 1985 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LLW/K850437

## Device Facts

- **Applicant:** Vital Signs, Inc.
- **Product Code:** [LLW](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LLW.md)
- **Decision Date:** Feb 14, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4550
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LLW/K850437](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LLW/K850437)

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