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

    NuEra Tight RF, NuEra Tight RF Plus

    K Number: K210867 · Decision Apr 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    77
    Applicant Total
    14
    Review Days
    29

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    Basic Information

    Device Name
    NuEra Tight RF, NuEra Tight RF Plus
    K Number
    K210867
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bios S.R.L.
    Date Received
    March 23, 2021
    Decision Date
    April 21, 2021
    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
    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
    K151296 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
    Search all 14 clearances from Bios S.R.L. →