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) → OUB — Instrument For Treatment Of Hyperhidrosis

# OUB · Instrument For Treatment Of Hyperhidrosis

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

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

## Overview

- **Product Code:** OUB
- **Device Name:** Instrument For Treatment Of Hyperhidrosis
- **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)
- **3rd-party reviewable:** yes

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K150419](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUB/K150419.md) | miraDry System MD4000 | Miramar Labs, Inc. | Jun 19, 2015 | SESE |
| [K131162](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUB/K131162.md) | MIRADRY SYSTEM | Miramar Labs, Inc. | Oct 25, 2013 | SESE |
| [K103014](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OUB/K103014.md) | MIRADRY SYSTEM | Miramar Labs, Inc. | Jan 28, 2011 | SESE |

## Top Applicants

- Miramar Labs, Inc. — 3 clearances

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

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