BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FX405

    DI: 00858985006193 · Model: MLS-AC · ERCHONIA CORPORATION, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FX405
    Primary DI
    00858985006193
    Version / Model
    MLS-AC
    Company Name
    ERCHONIA CORPORATION, LLC
    Labeler DUNS
    004053174
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-10
    Public Version
    5
    Public Version Date
    2023-11-03
    Public Version Status
    Update
    Public Device Record Key
    2f10c9f1-595a-49c0-8cb9-4ae861164e6c

    Device Description

    MEDICAL - Floor Model Low Level Laser - 3 diodes 17.5mW 635nm - 1 diode 23mW 405nm - IFU Pain Reduction, Acne Reduction

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

    GMDN Terms

    Code Name
    60409 Musculoskeletal/physical therapy laser, professional

    Identifiers

    Type ID
    Primary 00858985006193