BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SoLa Therapy Laser

    DI: 00854103007066 · Model: LTC-1510-SOLA · LITECURE LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SoLa Therapy Laser
    Primary DI
    00854103007066
    Version / Model
    LTC-1510-SOLA
    Company Name
    LITECURE LLC
    Labeler DUNS
    858768943
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-20
    Public Version
    2
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    f2d0d6e0-0330-4961-8d41-08e31a8bb2ac

    Device Description

    Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display

    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
    Yes
    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 00854103007066