BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SR 580

    Reg #: 3006716777 · FEI: 3006716777 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHARPLIGHT TECHNOLOGIES LTD.
    Registration Number
    3006716777
    FEI Number
    3006716777
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    33 lazarov st.
    City
    RISHON LEZION Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K111303

    Owner / Operator

    Firm Name
    SharpLight Technologies Ltd.
    Operator Number
    9094019
    Address
    33 Lazarov St., --
    City
    Rishon Le'Zion
    State
    Central
    Postal Code
    7565435
    Country
    IL
    Correspondent
    Yura - Isacov

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    SR 580 Omnimax VP 535 Omnimax S3 MaxHR580 Formax MaxVP2 535 Formax Plus MaxQS Nd:YAG 1064/532 QS Laser HR 580 MaxAC415 LP Laser 1064 Fractional Laser 2940 MaxIR face 850-1750 HR 635 DUAL VP MaxHR635 HR 730 MaxVP535 MaxSR580 MaxEr.YAG 2940 Fractional AC 420 MaxHR730 IR 6.4 Omnimax S4 IR 3.4

    Establishment Types

    Manufacture Medical Device