Devices

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.

Model / Serial
MN-MD4000-MC, all units
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
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.
Manufacturer
Miramar Labs, Inc.
1 Event
- Recall of 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.

Manufacturer

Miramar Labs, Inc.

Manufacturer Address
Miramar Labs, Inc., 2790 Walsh Ave, Santa Clara CA 95051-0963
Manufacturer Parent Company (2017)
Sientra Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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