BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEALITE II SYSTEM

    Reg #: 1222993 · FEI: 1000120578 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    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
    K113668

    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
    Lamp, Infrared, Therapeutic Heating ILY

    Proprietary Names

    HEALITE II SYSTEM

    Establishment Types

    Repack or Relabel Medical Device