BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PURE Laser, EPL810 HP

    DI: 07290016814378 · Model: EPL810 HP · ENDYMED MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PURE Laser, EPL810 HP
    Primary DI
    07290016814378
    Version / Model
    EPL810 HP
    Catalog Number
    ND_PRD00459-00
    Company Name
    ENDYMED MEDICAL LTD
    Labeler DUNS
    531958689
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-19
    Public Version
    2
    Public Version Date
    2024-02-16
    Public Version Status
    Update
    Public Device Record Key
    2e5ed0fa-6d38-4d07-9b5b-0c298e261f47

    Device Description

    The handpiece of the PURE Laser system which delivers pulsed laser light (wavelength 810nm) from the diode array to the treatment area.

    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
    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
    65509 Dermatological laser beam producing handpiece

    Identifiers

    Type ID
    Primary 07290016814378

    Customer Contacts

    Phone
    1-855-363-9633
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K222369 000