BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZELTIQ AESTHETICS, INC.

    Reg #: 3007215625 · FEI: 3007215625 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ZELTIQ AESTHETICS, INC.
    Registration Number
    3007215625
    FEI Number
    3007215625
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4410 Rosewood Dr
    City
    Pleasanton
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142491

    Owner / Operator

    Firm Name
    ZELTIQ Aesthetics, Inc.
    Operator Number
    10025698
    Address
    4410 Rosewood Drive
    City
    Pleasanton
    State
    CA
    Postal Code
    94588
    Country
    US
    Correspondent
    Difei Chai

    Products

    Device Name Product Code
    Dermal Cooling Pack/Vacuum/Massager OOK
    Brush, Dermabrasion, Powered GFE

    Proprietary Names

    CoolSculpting System ZELTIQ Breeze System SilkPeel Spa DPRO EnDoucer Dermolissage SilkPeel MD SilkPeel Pro SP3 Silk Peel Dermalinfusion CoolSculpting Elite System ZELTIQ System

    Establishment Types

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