BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    APL MEDICAL SYSTEM

    K Number: K072344 · Decision Dec 3, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    14
    Review Days
    104

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    APL MEDICAL SYSTEM
    K Number
    K072344
    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
    Bios S.R.L.
    Date Received
    August 21, 2007
    Decision Date
    December 3, 2007
    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.

    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

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

    PICOSURE WORKSTATION

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

    LumiGlam Laser System (SHE-LSP601-3)

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

    LASEmaR 1500

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

    LUNE PureHygiene

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

    Boston 2910 (Boston 2910)

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

    Other Clearances by Bios S.R.L.

    K Number Device Name
    K243445 Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
    K241407 Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
    K230755 NuEra Tight RF Model OptiStream
    K223856 NuEra Tight RF Family
    K223907 NuEra Tight RF Model APMD145.M70-US
    K210867 NuEra Tight RF, NuEra Tight RF Plus
    K201239 NuEra Tight Family, EMS Model
    K200359 NuEra Tight, NuEra Tight EMS
    K161632 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
    K153229 Superbium
    Search all 14 clearances from Bios S.R.L. →