BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PEACH 2 go

    DI: 07350120791917 · Model: Arctic Blue · Foreo AB
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PEACH 2 go
    Primary DI
    07350120791917
    Version / Model
    Arctic Blue
    Company Name
    Foreo AB
    Labeler DUNS
    352394143
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-07
    Public Version
    1
    Public Version Date
    2024-08-15
    Public Version Status
    New
    Public Device Record Key
    ffac4ab0-9a4d-4eb7-981d-7c51e3e3745a

    Device Description

    PEACH™ 2 go is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.

    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    65776 Home-use intense pulsed light hair removal unit

    Identifiers

    Type ID
    Primary 07350120791917

    Premarket Submissions

    Submission Number Supplement Number
    K231977 000