BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro

    DI: 17290110121942 · Model: 02 · ALMA LASERS LTD.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro
    Primary DI
    17290110121942
    Version / Model
    02
    Catalog Number
    AAHP08031503WR0002
    Company Name
    ALMA LASERS LTD.
    Labeler DUNS
    532283264
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-24
    Public Version
    2
    Public Version Date
    2023-02-03
    Public Version Status
    Update
    Public Device Record Key
    2f528dfe-c08c-4c49-9066-2ca581c2c1f7

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument
    FTC Light, Ultraviolet, Dermatological
    HHR Laser, Surgical, Gynecologic
    LNK Laser For Gastro-Urology Use

    GMDN Terms

    Code Name
    45220 Multi-modality skin surface treatment system

    Identifiers

    Type ID
    Primary 17290110121942

    Premarket Submissions

    Submission Number Supplement Number
    K072564 000