BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CLARITY II

    DI: 08809447655673 · Model: 3mm, 5mm cartridge · Lutronic Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CLARITY II
    Primary DI
    08809447655673
    Version / Model
    3mm, 5mm cartridge
    Company Name
    Lutronic Corporation
    Labeler DUNS
    688282516
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-27
    Public Version
    1
    Public Version Date
    2025-09-04
    Public Version Status
    New
    Public Device Record Key
    d4f60ca0-1ee7-48e7-8ad7-14d298b2ee23

    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
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    47883 Dermatological solid-state laser system

    Identifiers

    Type ID
    Primary 08809447655673