BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dental Diode Laser System

    DI: 06970750060088 · Model: SOLASE-808 · LAZON Medical Laser Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dental Diode Laser System
    Primary DI
    06970750060088
    Version / Model
    SOLASE-808
    Catalog Number
    08
    Company Name
    LAZON Medical Laser Co., Ltd.
    Labeler DUNS
    544395883
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-08
    Public Version
    1
    Public Version Date
    2019-02-08
    Public Version Status
    New
    Public Device Record Key
    0fa71c3b-6363-4e24-b20e-af92fa9bd70d

    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
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Primary 06970750060088

    Premarket Submissions

    Submission Number Supplement Number
    K180967 000