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

    NuEra Tight, NuEra Tight EMS

    K Number: K200359 · Decision Aug 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    77
    Applicant Total
    14
    Review Days
    180

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    Basic Information

    Device Name
    NuEra Tight, NuEra Tight EMS
    K Number
    K200359
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bios S.R.L.
    Date Received
    February 13, 2020
    Decision Date
    August 11, 2020
    Product Code
    PBX
    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

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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
    K161632 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
    K153229 Superbium
    K151296 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
    Search all 14 clearances from Bios S.R.L. →