BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GentleMax Pro Plus

    K Number: K201111 · Decision May 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    8
    Review Days
    29

    Basic Information

    Device Name
    GentleMax Pro Plus
    K Number
    K201111
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Candela Corporation
    Date Received
    April 27, 2020
    Decision Date
    May 26, 2020
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.

    AviClear Laser System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Pastelle

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SurgiLight 1470 Diode Laser System (Model:Halo)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AuroLase® System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Diode laser device (RF3120-BI)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Candela Corporation

    K Number Device Name
    K240070 Profound Matrix
    K230990 Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
    K220853 PicoWay Laser System
    K212492 Frax 1940 for Nordlys and Frax Pro
    K211217 Profound Matrix
    K191685 PicoWay Laser System
    K150326 PicoWay Laser System