← Product Code [EWG](/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG) · K870587

# LASERMATIC SURGILASER MODEL 5050 (K870587)

_Lasermatic OY · EWG · Aug 10, 1988 · Ear, Nose, Throat · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG/K870587

## Device Facts

- **Applicant:** Lasermatic OY
- **Product Code:** [EWG](/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG.md)
- **Decision Date:** Aug 10, 1988
- **Decision:** SN
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG/K870587](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EWG/K870587)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
