BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Drx SpectraLite Faceware

    DI: B347BA5672100 · Model: BA567210 · LED TECHNOLOGIES INC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Drx SpectraLite Faceware
    Primary DI
    B347BA5672100
    Version / Model
    BA567210
    Company Name
    LED TECHNOLOGIES INC
    Labeler DUNS
    197386191
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-30
    Public Version
    3
    Public Version Date
    2024-02-13
    Public Version Status
    Update
    Public Device Record Key
    7402131b-d639-48d1-b5f5-51d86e7ae42e
    Distribution End Date
    2024-02-12

    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
    No
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne
    OHS Light Based Over The Counter Wrinkle Reduction

    GMDN Terms

    Code Name
    62202 Blue/red/infrared phototherapy lamp

    Identifiers

    Type ID
    Package B347BA5672101
    Primary B347BA5672100
    Package B347BA5672102