# Miradry System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/miradry-system-oub-k103014>
- Manufacturer: [Miramar Labs, Inc.](https://devicerts.com/manufacturers/miramar-labs-inc) (United States, FDA 510(k) applicant)
- Name in the registry: MIRADRY SYSTEM
- Device class: Class II (US FDA)
- FDA product code: OUB

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K103014 · decision 2011-01-28 · decision SESE · status: Active

## Recalls

- Z-0234-2016 · Class II · terminated · initiated 2015-10-09: Update to labeling for the miraDry Console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
- Z-2591-2011 ·  · terminated · initiated 2011-04-24: Reports of skin burns on axilla after treatment with the miraDry System.

## Identifiers

- 510(k) Number: K103014 [FDA 510(k)]
- FDA product code: OUB [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4400 [FDA 510(k)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Miradry System, Miramar Labs, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/miradry-system-oub-k103014 (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-11
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/miradry-system-oub-k103014.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/miradry-system-oub-k103014
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.