BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GentleLase Pro LE

    Reg #: 3016496662 · FEI: 3016496662 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Candela Corporation
    Registration Number
    3016496662
    FEI Number
    3016496662
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    251 Locke Drive
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140732

    Owner / Operator

    Firm Name
    Candela Corporation
    Operator Number
    1218402
    Address
    251 Locke Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Greg Wallender

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    GentleLase Pro LE GentleLase Pro GentleTouch GentleMax Pro, GentleLase Pro U, GentleYag Pro U The Gentle Family, Gentle Pro Series

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198