BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    D-STORM

    Reg #: 3005801723 · FEI: 3005801723 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    LIGHT INSTRUMENTS Ltd.
    Registration Number
    3005801723
    FEI Number
    3005801723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Hatnufa Street, Yokneam
    City
    Yokneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K093048

    Owner / Operator

    Firm Name
    LIGHT INSTRUMENTS Ltd.
    Operator Number
    9089640
    Address
    4 Hatnufa Street
    City
    Yokneam
    State
    Northern
    Postal Code
    2066717
    Country
    IL
    Correspondent
    Ariela Albalak

    US Agent

    Business Name
    Sterling Medical Devices, LLC DBA Vantage MedTech
    Contact Name
    Indre Larson
    Address
    250 Moonachie Rd
    City
    Moonachie
    State
    NJ
    ZIP
    07074
    Country
    US
    Email
    [email protected]
    Phone
    551 2206652

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    D-STORM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device