BEUDAMED
    FDA Registration Active 🇺🇸 United States

    miraDry System

    Reg #: 3008082710 · FEI: 3008082710 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    miraDry, Inc.
    Registration Number
    3008082710
    FEI Number
    3008082710
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    721 Charcot Ave
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150419

    Owner / Operator

    Firm Name
    miraDry Inc.
    Operator Number
    10082621
    Address
    721 Charcot Ave
    City
    San Jose
    State
    CA
    Postal Code
    95131
    Country
    US
    Correspondent
    Irene Mo

    Products

    Device Name Product Code
    Instrument For Treatment Of Hyperhidrosis OUB
    System, Ablation, Microwave And Accessories NEY
    System, Microwave, Hair Removal MWY

    Proprietary Names

    miraDry System

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198