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Bios S.R.L.

Vimodrone, IT · 8 510(k) clearances

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Total clearances
8
2020-08-11 → 2024-12-30
Last 12 months
0
Product codes
4
Most recent
2024-12-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PBX — — — 4 2023-10-30
GEX Powered Laser Surgical Instrument Class II General, Plastic Surgery 2 2024-12-30
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 1 2023-08-11
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Class II Physical Medicine 1 2020-12-31
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2024-12-30 K243445 Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) GEX Class II General, Plastic Surgery
2024-06-14 K241407 Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) GEX Class II General, Plastic Surgery
2023-10-30 K230755 NuEra Tight RF Model OptiStream PBX — —
2023-08-11 K223856 NuEra Tight RF Family GEI Class II General, Plastic Surgery
2023-05-02 K223907 NuEra Tight RF Model APMD145.M70-US PBX — —
2021-04-21 K210867 NuEra Tight RF, NuEra Tight RF Plus PBX — —
2020-12-31 K201239 NuEra Tight Family, EMS Model NGX Class II Physical Medicine
2020-08-11 K200359 NuEra Tight, NuEra Tight EMS PBX — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence