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

    BIOSYAG MEDICAL SYSTEM

    K Number: K080374 · Decision May 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    14
    Review Days
    93

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    Basic Information

    Device Name
    BIOSYAG MEDICAL SYSTEM
    K Number
    K080374
    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
    February 12, 2008
    Decision Date
    May 15, 2008
    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

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    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. →