FDA 510(k) Applications Submitted by BIOS S.R.L.

FDA 510(k) Number Submission Date Device Name Applicant
K072344 08/21/2007 APL MEDICAL SYSTEM BIOS S.R.L.
K080374 02/12/2008 BIOSYAG MEDICAL SYSTEM BIOS S.R.L.
K043521 12/20/2004 BIOSYAG 50 MED BIOS S.R.L.
K210867 03/23/2021 NuEra Tight RF, NuEra Tight RF Plus BIOS s.r.l.
K223856 12/23/2022 NuEra Tight RF Family BIOS s.r.l.
K223907 12/28/2022 NuEra Tight RF Model APMD145.M70-US BIOS s.r.l.
K200359 02/13/2020 NuEra Tight, NuEra Tight EMS Bios s.r.l.
K201239 05/07/2020 NuEra Tight Family, EMS Model Bios s.r.l.
K151296 05/15/2015 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) BIOS S.R.L.
K161632 06/13/2016 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) BIOS S.R.L.


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