BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Harmony Lite

    Reg #: 3004167969 · FEI: 3004167969 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ALMA LASERS LTD.
    Registration Number
    3004167969
    FEI Number
    3004167969
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18 Haharash Street, NORTH INDUSTRIAL PARK
    City
    CAESAREA Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K141237

    Owner / Operator

    Firm Name
    ALMA LASERS LTD.
    Operator Number
    9055441
    Address
    485 half day rd
    City
    Buffalo Grove
    State
    IL
    Postal Code
    60089
    Country
    US
    Correspondent
    Avi - Farbstein

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    Harmony Lite

    Establishment Types

    Manufacture Medical Device