BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-Laser

    DI: B317KCUBE0 · Model: K-Laser Cube · ELTECH KLASER SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K-Laser
    Primary DI
    B317KCUBE0
    Version / Model
    K-Laser Cube
    Company Name
    ELTECH KLASER SRL
    Labeler DUNS
    654931570
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-06
    Public Version
    7
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    992faf1c-c278-4640-9c9c-8ff6128b1379

    Device Description

    Device indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    60409 Musculoskeletal/physical therapy laser, professional

    Identifiers

    Type ID
    Primary B317KCUBE0