BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MD Elite LaserPro

    DI: 00860007876813 · Model: LaserPro · MDElite Laser and Aesthetic, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MD Elite LaserPro
    Primary DI
    00860007876813
    Version / Model
    LaserPro
    Company Name
    MDElite Laser and Aesthetic, LLC
    Labeler DUNS
    118440103
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-28
    Public Version
    3
    Public Version Date
    2023-10-23
    Public Version Status
    Update
    Public Device Record Key
    c2401989-094b-4b20-8bd4-47a2f08437b2

    Device Description

    MD Elite LaserPro - Diode Laser System - FDA 510(k) K212478

    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
    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
    58786 Dermatological diode laser system

    Identifiers

    Type ID
    Primary 00860007876813