← Product Code [HHR](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR) · K871579

# MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE (K871579)

_Sharplan Lasers, Inc. · HHR · Nov 16, 1987 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K871579

## Device Facts

- **Applicant:** Sharplan Lasers, Inc.
- **Product Code:** [HHR](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR.md)
- **Decision Date:** Nov 16, 1987
- **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/HHR/K871579](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHR/K871579)

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