Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4550](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4550) → LLW — Laser, Neodymium:Yag For Gynecologic Use

# LLW · Laser, Neodymium:Yag For Gynecologic Use

_Obstetrics/Gynecology · 21 CFR 884.4550 · Class 2_

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

## Overview

- **Product Code:** LLW
- **Device Name:** Laser, Neodymium:Yag For Gynecologic Use
- **Regulation:** [21 CFR 884.4550](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4550)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K850437](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/LLW/K850437.md) | DISPOSABLE LARYNGOSCOPE | Vital Signs, Inc. | Feb 14, 1985 | SESE |

## Top Applicants

- Vital Signs, Inc. — 1 clearance

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

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