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

    SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM

    K Number: K140009 · Decision Aug 29, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    11
    Review Days
    239

    Basic Information

    Device Name
    SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
    K Number
    K140009
    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
    ALMA LASERS LTD.
    Date Received
    January 2, 2014
    Decision Date
    August 29, 2014
    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 ALMA LASERS LTD.

    K Number Device Name
    K140005 ALMA DIODE TABLETOP LASER
    K090571 ALMA LASERS ALEX755 MODULE
    K083848 ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
    K082622 ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE
    K080463 ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
    K072182 ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
    K072564 ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
    K080318 ALMA LASER NIR MODULE
    K072699 ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL
    K070004 ACCENT
    Search all 11 clearances from ALMA LASERS LTD. →