← Product Code [LMS](/submissions/EN/subpart-e%E2%80%94surgical-devices/LMS) · K855146

# LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL (K855146)

_Laserscope · LMS · Apr 11, 1986 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LMS/K855146

## Device Facts

- **Applicant:** Laserscope
- **Product Code:** [LMS](/submissions/EN/subpart-e%E2%80%94surgical-devices/LMS.md)
- **Decision Date:** Apr 11, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4490
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

The argon laser device for use in otology, rhinology, and laryngology is an electro-optical device which produces coherent, electromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the device is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue. In rhinology and laryngology, the device is used to coagulate and vaporize soft and fibrous tissues, but not including osseous tissues.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LMS/K855146](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/LMS/K855146)

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