Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → MWY — System, Microwave, Hair Removal

# MWY · System, Microwave, Hair Removal

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

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

## Overview

- **Product Code:** MWY
- **Device Name:** System, Microwave, Hair Removal
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K010589](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MWY/K010589.md) | MICROWAVAE DELIVERY SYSTEM #MW2000 | Mw Medical, Inc. | Mar 19, 2001 | SESE |
| [K991456](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MWY/K991456.md) | MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 | Microwave Medical, Inc. | Oct 25, 1999 | SESE |

## Top Applicants

- Microwave Medical, Inc. — 1 clearance
- Mw Medical, Inc. — 1 clearance

---

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

**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
