BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Genesis Skye

    DI: 00850001456647 · Model: GSKYE · Omm Imports Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Genesis Skye
    Primary DI
    00850001456647
    Version / Model
    GSKYE
    Company Name
    Omm Imports Inc.
    Labeler DUNS
    010000704
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-28
    Public Version
    1
    Public Version Date
    2024-09-05
    Public Version Status
    New
    Public Device Record Key
    6deb488c-052e-414a-8cfe-55b82ce29c29
    Distribution End Date
    2031-07-01

    Device Description

    Over the counter blue LED phototherapy device for the treatment of acne.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne

    GMDN Terms

    Code Name
    62414 Blue-light phototherapy lamp, home-use

    Identifiers

    Type ID
    Primary 00850001456647