BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    LASEMD Laser System

    K Number: K171009 · Decision Jun 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    8
    Review Days
    80

    Basic Information

    Device Name
    LASEMD Laser System
    K Number
    K171009
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lutronic Corporation
    Date Received
    April 4, 2017
    Decision Date
    June 23, 2017
    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 Lutronic Corporation

    K Number Device Name
    K213748 CoreLevee
    K213569 HOLLYWOOD SPECTRA Laser System
    K203788 DermaV Laser System
    K183566 CLARITY II Laser System
    K180945 LUTRONIC GENIUS Radiofrequency System
    K173700 PICOPLUS Laser System
    K153769 R:GEN Laser System