BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GentleWave System

    Reg #: 3010817521 · FEI: 3010817521 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SONENDO, INC.
    Registration Number
    3010817521
    FEI Number
    3010817521
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    26061 Merit Circle, Suite 101
    City
    Laguna Hills
    State
    CA
    ZIP
    92653
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160905

    Owner / Operator

    Firm Name
    Sonendo, Inc.
    Operator Number
    10046931
    Address
    26061 Merit Circle, Suite 101
    City
    Laguna Hills
    State
    CA
    Postal Code
    92653
    Country
    US
    Correspondent
    Amanda N Coy

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC

    Proprietary Names

    GentleWave System

    Establishment Types

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