← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K970243

# CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR (K970243)

_Cynosure, Inc. · GEX · Jun 3, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970243

## Device Facts

- **Applicant:** Cynosure, Inc.
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** Jun 3, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970243](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970243)

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