← Product Code [EWG](/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG) · K864975

# LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) (K864975)

_Laserscope · EWG · Feb 25, 1987 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG/K864975

## Device Facts

- **Applicant:** Laserscope
- **Product Code:** [EWG](/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG.md)
- **Decision Date:** Feb 25, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4500
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG/K864975](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG/K864975)

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