Bios S.r.l.
FDA Regulatory Profile
Bios S.r.l. appears in FDA public data with 1 recall, 15 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0052-2018, Class II) was initiated on July 13, 2017. Its most recent 510(k) clearance was granted on December 30, 2024.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0052-2018 | Class II | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue | July 13, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | December 30, 2024 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | June 14, 2024 |
| K230755 | NuEra Tight RF Model OptiStream | October 30, 2023 |
| K223856 | NuEra Tight RF Family | August 11, 2023 |
| K223907 | NuEra Tight RF Model APMD145.M70-US | May 2, 2023 |
| K210867 | NuEra Tight RF, NuEra Tight RF Plus | April 21, 2021 |
| K201239 | NuEra Tight Family, EMS Model | December 31, 2020 |
| K200359 | NuEra Tight, NuEra Tight EMS | August 11, 2020 |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | December 8, 2016 |
| K153229 | Superbium | April 12, 2016 |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | November 19, 2015 |
| K080374 | BIOSYAG MEDICAL SYSTEM | May 15, 2008 |
| K072344 | APL MEDICAL SYSTEM | December 3, 2007 |
| K043521 | BIOSYAG 50 MED | March 24, 2005 |
| K780510 | NUCLEAR STETHOSCOPE | April 18, 1978 |