NuEra Tight RF Model APMD145.M70-US— 510(k) K223907

Name: FDA 510(k) clearance K223907
Creator: U.S. Food and Drug Administration
Published: 2023-05-02

Substantially Equivalent

Bios S.R.L.

FDA 510(k) clearance K223907 for NuEra Tight RF Model APMD145.M70-US, Substantially Equivalent on 2023-05-02. 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: 2022-12-28
Decision date: 2023-05-02
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.