BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LEAP Laser Delivery Tip

    DI: 00872320006846 · Model: 05083 · CAO GROUP, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LEAP Laser Delivery Tip
    Primary DI
    00872320006846
    Version / Model
    05083
    Company Name
    CAO GROUP, INC.
    Labeler DUNS
    102422578
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-10
    Public Version
    1
    Public Version Date
    2026-04-20
    Public Version Status
    New
    Public Device Record Key
    01340c2d-564d-4ec6-bbd1-1f18692e4ae9

    Device Description

    Optical fiber delivery tip, for use with the Picasso Pro Diode Laser for the LEAP treatment procedure.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Liquid Chemical

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument
    NVK Laser, Dental, Soft Tissue

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Package 00872320006563
    Primary 00872320006846

    Customer Contacts

    Phone
    866-999-2635
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K254197 000