BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PICOSURE WORKSTATION WITH 1064NM LASER DELIVERY SYSTEM

    Reg #: 1222993 · FEI: 1000120578 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    CYNOSURE, LLC
    Registration Number
    1222993
    FEI Number
    1000120578
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5 CARLISLE RD
    City
    Westford
    State
    MA
    ZIP
    01886
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160480

    Owner / Operator

    Firm Name
    CYNOSURE, LLC
    Operator Number
    9006419
    Address
    5 CARLISLE ROAD, --
    City
    Westford
    State
    MA
    Postal Code
    01886
    Country
    US
    Correspondent
    Nicole - Getman

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    PICOSURE WORKSTATION WITH 1064NM LASER DELIVERY SYSTEM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device