BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FAQ 201

    DI: 07640260120167 · Model: Pink Ruby · Foreo AB
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FAQ 201
    Primary DI
    07640260120167
    Version / Model
    Pink Ruby
    Company Name
    Foreo AB
    Labeler DUNS
    352394143
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-24
    Public Version
    1
    Public Version Date
    2024-05-02
    Public Version Status
    New
    Public Device Record Key
    e56adebd-b216-4664-87a9-3df21119c1e1

    Device Description

    FAQ™ 201 is intended to use LED light for the treatment of wrinkles and mild to moderate 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
    OHS Light Based Over The Counter Wrinkle Reduction
    OLP Over-The-Counter Powered Light Based Laser For Acne

    GMDN Terms

    Code Name
    62202 Blue/red/infrared phototherapy lamp

    Identifiers

    Type ID
    Primary 07640260120167

    Premarket Submissions

    Submission Number Supplement Number
    K240378 000