BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Platinum

    DI: B679SLP10 · Model: SLP1 · SUMMUS MEDICAL LASER, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Platinum
    Primary DI
    B679SLP10
    Version / Model
    SLP1
    Catalog Number
    SLP1
    Company Name
    SUMMUS MEDICAL LASER, LLC
    Labeler DUNS
    621560338
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-14
    Public Version
    2
    Public Version Date
    2022-12-08
    Public Version Status
    Update
    Public Device Record Key
    b7236359-6f13-4dfe-9cc4-b64eb145593b

    Device Description

    Light weight (~3 Kg.) and portable therapeutic medical laser device (measuring ~195 mm x 195 mm x 275 mm) indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments are in the form of non-ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.

    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 B679SLP10

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 35 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 30 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    0 – 80 Percent (%) Relative Humidity
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 75 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    86 – 106 KiloPascal