BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Hybrid System 30W 120V 50/60 HZ

    DI: 17290110122093 · Model: 1 · ALMA LASERS LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Hybrid System 30W 120V 50/60 HZ
    Primary DI
    17290110122093
    Version / Model
    1
    Catalog Number
    AACO15061980BDAZ0004
    Company Name
    ALMA LASERS LTD.
    Labeler DUNS
    532283264
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-11
    Public Version
    2
    Public Version Date
    2023-02-03
    Public Version Status
    Update
    Public Device Record Key
    13a0df0c-fba2-4e51-b83b-7b9e7ef65291
    Distribution End Date
    2021-07-11

    Device Description

    Hybrid System 30W 120V 50/60 HZ

    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
    Yes
    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    45220 Multi-modality skin surface treatment system

    Identifiers

    Type ID
    Primary 17290110122093

    Premarket Submissions

    Submission Number Supplement Number
    K203441 000