Recall Z-0234-2016— Miramar Labs, Inc.

Name: FDA recall Z-0234-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-09

Class II · Terminated

Class II FDA medical device recall by Miramar Labs, Inc., initiated 2015-10-09, terminated 2015-12-23. It names 3 FDA 510(k) clearances: K150419, K131162, K103014. Product: miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.. Reason: 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..

Recalling firm: Miramar Labs, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-09
Terminated: 2015-12-23
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

3 on FDA's record

K150419 — miraDry System MD4000Miramar Labs, Inc.·cleared 2015-06-19
K131162 — MIRADRY SYSTEMMiramar Labs, Inc.·cleared 2013-10-25
K103014 — MIRADRY SYSTEMMiramar Labs, Inc.·cleared 2011-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.