FDA-Device2015-11-18Class II
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.
Miramar Labs, Inc.
Hazard
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.
Sold states
Nationwide Distribution
Affected count
277 units
Manufactured in
2790 Walsh Ave, N/A, Santa Clara, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2016Don't want to check this manually?
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