Devices

MiraDry System

  • Modèle / numéro de série
    Serial numbers: 10H0158, 10H0160, 10H0161, 10H0167, 10H0172, 10H0185, 10H0193, 11H0035.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International only: Japan
  • Description du dispositif
    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

Fabricant

Miramar Labs, Inc.
  • Adresse du fabricant
    Miramar Labs, Inc., 445 Indio Way, Sunnyvale CA 94085-4203
  • Société-mère du fabricant (2017)
    Sientra Inc.
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

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miraDry System
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD40...
  • Modèle / numéro de série
    MN-MD4000-MC, all units
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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)
  • Modèle / numéro de série
    miraDry System (used for the treatment of primary axillary hyperhidrosis)All batches affectedARTG Number: 223967
  • Manufacturer
    Device Consulting Pty Ltd