BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    LUSTRE ClearSkin REVIVE LED Light Therapy Mask

    Reg #: 3018188770 · FEI: 3018188770 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Lustreskin
    Registration Number
    3018188770
    FEI Number
    3018188770
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Alba Innovation Centre, Alba Campus
    City
    Livingston Scotland
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K202390

    Owner / Operator

    Firm Name
    Lustreskin
    Operator Number
    10080478
    Address
    Alba Innovation Centre, Alba Campus
    City
    Livingston
    State
    Scotland
    Postal Code
    EH54 7GA
    Country
    GB
    Correspondent
    Graeme Low

    US Agent

    Business Name
    Smith Associates
    Contact Name
    Kristi Leigh
    Address
    1468 Harwell Ave
    City
    Crofton
    State
    MD
    ZIP
    21114
    Country
    US
    Email
    [email protected]
    Phone
    888 7299674 ext. 203

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY
    Light Based Over The Counter Wrinkle Reduction OHS
    Over-The-Counter Powered Light Based Laser For Acne OLP

    Proprietary Names

    LUSTRE ClearSkin REVIVE LED Light Therapy Mask

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198