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Bios S.R.L.

Country not established FDA

Devices
14
Registrations
FDA
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment, FDA recalls

What Bios S.R.L. makes

Bios S.R.L. manufactures radiofrequency (RF) and laser-based medical devices for cosmetic and dermatological treatments, including systems for skin tightening, hair removal, and tissue rejuvenation. Their portfolio includes RF devices like the NuEra Tight series, designed for non-invasive skin remodeling, as well as laser systems such as the Splendor X and Family of Square Epil for hair removal and skin treatments. Additional offerings include the BIOSYAG and APL Medical Systems for specialized medical applications.

The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. These products are intended for use in the United States, where regulatory compliance is required for market authorization. No additional registries or classifications are specified.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

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Rows 1-14 of 14

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2017

    • 13 Jul 2017 Z-0052-2018 Class II Terminated In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.via FDA establishment BIOS S.R.L. Distribution: AZ, AR, CA, FL, GA, ID, IL, KS, LA, MA, MI, MS, MO, NV, NJ, NM, NY, OH, OR, PA, SD, TX, WA, WI, and WV Brazil, Canada,…
      Full distribution text AZ, AR, CA, FL, GA, ID, IL, KS, LA, MA, MI, MS, MO, NV, NJ, NM, NY, OH, OR, PA, SD, TX, WA, WI, and WV Brazil, Canada, Israel, Japan, & Thailand.
      Submission number: K151296

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Bios S.R.L. VIMODRONE Milano · IT FEI 3008108972

Frequently asked questions

How many devices does Bios S.R.L. have in the registry?

The registry currently lists 14 devices for Bios S.R.L.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bios S.R.L.'s devices?

Among its 14 most recently registered devices, Bios S.R.L. has devices listed in FDA 510(k) (14 devices).

What risk classes do Bios S.R.L.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Bios S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Bios S.R.L.?

FDA recall records list 1 recall initiated by Bios S.R.L., the most recent initiated on 2017-07-13. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Bios S.R.L. in the registry?

The most recently registered devices listed for Bios S.R.L. include NuEra Tight RF Model APMD145.M70-US, NuEra Tight RF Family, Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) and BIOSYAG MEDICAL SYSTEM.

Which FDA establishments are linked to Bios S.R.L.?

1 FDA establishment is linked to Bios S.R.L. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.