Devices

MiraDry System

  • Model / Serial
    Serial numbers: 10H0158, 10H0160, 10H0161, 10H0167, 10H0172, 10H0185, 10H0193, 11H0035.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International only: Japan
  • Product Description
    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.
  • Manufacturer
    Miramar Labs, Inc.
  • 1 Event

Manufacturer

Miramar Labs, Inc.
  • Manufacturer Address
    Miramar Labs, Inc., 445 Indio Way, Sunnyvale CA 94085-4203
  • Manufacturer Parent Company (2017)
    Sientra Inc.
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

miraDry System
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD40...
  • 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.
miraDry System (used for the treatment of primary axillary hyperhidrosis)
  • Model / Serial
    miraDry System (used for the treatment of primary axillary hyperhidrosis)All batches affectedARTG Number: 223967
  • Manufacturer
    Device Consulting Pty Ltd