BEUDAMED
    FDA Registration Active 🇺🇸 United States

    InnoVoyce VYLO Laser

    Reg #: 3024753061 · FEI: 3024753061 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INNOVOYCE
    Registration Number
    3024753061
    FEI Number
    3024753061
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    One Beacon St, Floor 15
    City
    Boston
    State
    MA
    ZIP
    02108
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240159

    Owner / Operator

    Firm Name
    InnoVoyce
    Operator Number
    10062599
    Address
    25 Dorchester Avenue, #52318
    City
    Boston
    State
    MA
    Postal Code
    02205
    Country
    US
    Correspondent
    Stephen Mais

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    InnoVoyce VYLO Laser

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility