# Bios S.R.L.

- Location (FDA's records): Vimodrone, IT
- FDA decisions: 15 (1978–2024): 15 510(k) clearances
- Names in FDA's records: Bios S.R.L. (14); Bios, Inc. (1)
- Product codes: GEX (7), PBX (5), IYY (1), NGX (1), GEI (1)
- 510(k) review time since 2016: median 168 days, against 124 for FDA's reviews in the same codes and years (4 of 10 faster)
- Predicates its devices cite: 22 (9 its own); citations of its devices by later devices: 16 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Palomar Medical Technologies, Inc.: 2 (https://510kreport.com/company/palomar-medical-technologies)
- Msq (M2), Ltd.: 2 (https://510kreport.com/company/msq-m2)
- Cutera, Inc.: 1 (https://510kreport.com/company/cutera)
- Ellman International, Inc.: 1 (https://510kreport.com/company/ellman-international)
- BTL Industries, Inc.: 1 (https://510kreport.com/company/btl-industries)
- Alma Lasers, Inc.: 1 (https://510kreport.com/company/alma-lasers)
- Asclepion Laser Technologies GmbH: 1 (https://510kreport.com/company/asclepion-laser-technologies)
- Sharplight Technologies, Ltd.: 1 (https://510kreport.com/company/sharplight-technologies)

## Firms that cite its devices most
- Termosalud: 1 (https://510kreport.com/company/termosalud)
- Zimmer Medizinsysteme GmbH: 1 (https://510kreport.com/company/zimmer-medizinsysteme)
- Novasonix Technology S.L.: 1 (https://510kreport.com/company/novasonix-technology)
- BTL Industries, Inc.: 1 (https://510kreport.com/company/btl-industries)
- Mectronic Medicale S.R.L.: 1 (https://510kreport.com/company/mectronic-medicale)
- Beijing Syntech Laser CO., LTD.: 1 (https://510kreport.com/company/beijing-syntech-laser)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)

## Its most-cited devices
- K210867: NuEra Tight RF, NuEra Tight RF Plus (2021), cited by 4
- K200359: NuEra Tight, NuEra Tight EMS (2020), cited by 4
- K153229: Superbium (2016), cited by 2
- K072344: Apl Medical System (2007), cited by 2
- K151296: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) (2015), cited by 1
- K080374: Biosyag Medical System (2008), cited by 1

## Recent decisions
- K243445: Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (Dec 30, 2024)
- K241407: Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) (Jun 14, 2024)
- K230755: NuEra Tight RF Model OptiStream (Oct 30, 2023)
- K223856: NuEra Tight RF Family (Aug 11, 2023)
- K223907: NuEra Tight RF Model APMD145.M70-US (May 2, 2023)
- K210867: NuEra Tight RF, NuEra Tight RF Plus (Apr 21, 2021)
- K201239: NuEra Tight Family, EMS Model (Dec 31, 2020)
- K200359: NuEra Tight, NuEra Tight EMS (Aug 11, 2020)

Source page: https://510kreport.com/company/bios