BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ESPADA Acne-Clearing Blue Light Pen

    DI: 07350092130271 · Model: ESPADA Cobalt Blue · Foreo AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ESPADA Acne-Clearing Blue Light Pen
    Primary DI
    07350092130271
    Version / Model
    ESPADA Cobalt Blue
    Company Name
    Foreo AB
    Labeler DUNS
    352394143
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-09
    Public Version
    3
    Public Version Date
    2022-12-05
    Public Version Status
    Update
    Public Device Record Key
    c66d6bad-7d2a-4ef3-a491-e5fd3679bea3

    Device Description

    The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLP Over-The-Counter Powered Light Based Laser For Acne

    GMDN Terms

    Code Name
    62414 Blue-light phototherapy lamp, home-use

    Identifiers

    Type ID
    Primary 07350092130271

    Premarket Submissions

    Submission Number Supplement Number
    K162450 000