miraDry System

Serial numbers: 10H0158, 10H0160, 10H0161, 10H0167, 10H0172, 10H0185, 10H0193, 11H0035.

General and Plastic Surgery Devices

2

No

International only: Japan

MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece || (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. || Miramar Labs, Inc. || 445 Indio Way || Sunnyvale, CA 94085 || Intended use: Treatment of primary axillary hyperhidrosis.

MN-MD4000-MC, all units

General and Plastic Surgery Devices

2

No

Nationwide Distribution

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.

miraDry System (used for the treatment of primary axillary hyperhidrosis)All batches affectedARTG Number: 223967