BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    VIORA LTD.

    Reg #: 3005695724 · FEI: 3005695724 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    15
    Establishment Types
    3
    Classifications
    9

    Registration Details

    Registration Name
    VIORA LTD.
    Registration Number
    3005695724
    FEI Number
    3005695724
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Sagi 2000, Industrial Park
    City
    Migdal HaEmek Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K200468

    Owner / Operator

    Firm Name
    VIORA LTD.
    Operator Number
    9086237
    Address
    Sinclair Pharmaceuticals Limited, Eden House, Lakeside, Chester Business Park
    City
    Chester
    State
    Cheshire West and Chester
    Postal Code
    CH4 9QT
    Country
    GB

    US Agent

    Business Name
    Registrar corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177 ext. 200

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Massager, Therapeutic, Electric ISA
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Injector, Fluid, Non-Electrically Powered KZE
    Dermatome GFD
    Massager, Vacuum, Light Induced Heating NUV
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF

    Proprietary Names

    V20 System With V-FC_V-FC Pro , V30 System With V-FC_V-FC Pro, V10 System With V-FC_V-FC Pro V20 System V20 System with V-ST Handpiece, V-IPL Handpiece,V-FORM Handpiece with BC and FC Applicators Dermafuse Flat Single-Use Tip Brush Single-Use Tip V10 System and V20 System with V-FORM Handpiece with BC Small,Medium and Large Applicators V30 System with V-ST HP,V-IPL HP,V-Nd:YAG HP,V-FORM HP with BC Small,Medium, Large Applicators V30 V20 System With V-VR Handpiece , V30 System With V-VR Handpiece , V10 System With V-VR Handpiece V30 System With V-FR Handpiece, V20 System With V-FR Handpiece, V10 System With V-FR Handpiece V10 System with V-ST Handpiece and V-FORM Handpiece with BC and FC Applicators Pristine Reaction System Trios System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device