Data / Medical devices / Italy / Bios S.R.L.
Bios S.R.L.: FDA-registered device maker in VIMODRONE Milano, Italy, 8 510(k) clearances
Bios S.R.L. is registered with the FDA (registration 3004940677) in VIMODRONE Milano, Italy. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 30, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004940677
- FEI number
- 3008108972
- Address
- Via Guido Rossa, 10/12, VIMODRONE Milano, Italy, I-20055
- Owner or operator
- BIOS S.R.L. (9068895)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 10, 2017
- Registered through
- 2027
- Brand names listed
- NuEra Tight 1ch, NuEra Tight RF, NuEra Tight RF Plus, SPLENDOR X ALEX, SPLENDOR X ALEX + Nd:YAG, SPLENDOR X ALEX2, SPLENDOR X Nd:YAG, SQUARE EPIL ALEX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 30, 2024 | K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | GEX | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
| June 14, 2024 | K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | GEX | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
| October 30, 2023 | K230755 | NuEra Tight RF Model OptiStream | PBX | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
| August 11, 2023 | K223856 | NuEra Tight RF Family | GEI | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
| May 2, 2023 | K223907 | NuEra Tight RF Model APMD145.M70-US | PBX | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
| April 21, 2021 | K210867 | NuEra Tight RF, NuEra Tight RF Plus | PBX | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
| August 11, 2020 | K200359 | NuEra Tight, NuEra Tight EMS | PBX | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
| December 8, 2016 | K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | GEX | Substantially Equivalent | Bios S.R.L. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 13, 2017 | 77754 | Class II | Terminated | THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions. | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Powered Laser Surgical Instrument
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated December 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.