NuEra Tight RF, NuEra Tight RF Plus— 510(k) K210867

Name: FDA 510(k) clearance K210867
Creator: U.S. Food and Drug Administration
Published: 2021-04-21

Substantially Equivalent

Bios S.R.L.

FDA 510(k) clearance K210867 for NuEra Tight RF, NuEra Tight RF Plus, Substantially Equivalent on 2021-04-21. Applicant: Bios S.R.L.. Device class: 2.

Clearance details

Applicant: Bios S.R.L.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2021-03-23
Decision date: 2021-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Vimodrone, IT

Download summary PDF View on FDA.gov ↗

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K230755 — NuEra Tight RF Model OptiStream2023-10-30
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Data sourced from openFDA. This site is unofficial and independent of the FDA.