Bios S.R.L.
Medical device manufacturer in Vimodrone, IT.
14510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)GEX · Traditional | 12/30/2024SE |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)GEX · Traditional | 06/14/2024SE |
| K230755 | NuEra Tight RF Model OptiStreamPBX · Traditional | 10/30/2023SE |
| K223856 | NuEra Tight RF FamilyGEI · Traditional | 08/11/2023SE |
| K223907 | NuEra Tight RF Model APMD145.M70-USPBX · Special | 05/02/2023SE |
| K210867 | NuEra Tight RF, NuEra Tight RF PlusPBX · Special | 04/21/2021SE |
| K201239 | NuEra Tight Family, EMS ModelNGX · Traditional | 12/31/2020SE |
| K200359 | NuEra Tight, NuEra Tight EMSPBX · Traditional | 08/11/2020SE |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)GEX · Traditional | 12/08/2016SE |
| K153229 | SuperbiumGEX · Traditional | 04/12/2016SE |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)PBX · Traditional | 11/19/2015SE |
| K080374 | Biosyag Medical SystemGEX · Traditional | 05/15/2008SE |
| K072344 | Apl Medical SystemGEX · Traditional | 12/03/2007SE |
| K043521 | Biosyag 50 MedGEX · Traditional | 03/24/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0052-2018 Class II | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of…In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. | 07/13/2017Terminated |