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. |
| K241407 |
05/17/2024 |
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) |
Bios S.r.l. |
| K243445 |
11/06/2024 |
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) |
Bios S.r.l. |
| K230755 |
03/17/2023 |
NuEra Tight RF Model OptiStream |
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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