Company ยท IT
Bios S.R.L.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2024. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 30, 2024 | K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) Bios S.R.L., IT | GEX |
| Jun 14, 2024 | K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) Bios S.R.L., IT | GEX |
| Oct 30, 2023 | K230755 | NuEra Tight RF Model OptiStream Bios S.R.L., IT | PBX |
| Aug 11, 2023 | K223856 | NuEra Tight RF Family Bios S.R.L., IT | GEI |
| May 2, 2023 | K223907 | NuEra Tight RF Model APMD145.M70-US Bios S.R.L., IT | PBX |
| Apr 21, 2021 | K210867 | NuEra Tight RF, NuEra Tight RF Plus Bios S.R.L., IT | PBX |
| Dec 31, 2020 | K201239 | NuEra Tight Family, EMS Model Bios S.R.L., IT | NGX |
| Aug 11, 2020 | K200359 | NuEra Tight, NuEra Tight EMS Bios S.R.L., IT | PBX |
| Dec 8, 2016 | K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) Bios S.R.L., IT | GEX |
| Apr 12, 2016 | K153229 | Superbium Bios S.R.L., IT | GEX |
| Nov 19, 2015 | K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) Bios S.R.L., IT | PBX |
| May 15, 2008 | K080374 | BIOSYAG MEDICAL SYSTEM Bios S.R.L. | GEX |
| Dec 3, 2007 | K072344 | APL MEDICAL SYSTEM Bios S.R.L., IT | GEX |
| Mar 24, 2005 | K043521 | BIOSYAG 50 MED Bios S.R.L. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2017 | Bios S.r.l. THERMI250 Radiofrequency System.
Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions. Terminated |
PBX | K151296 |