510(k) Report

FDA applicant

Medency S.R.L.

Vicenza, IT2 decisions2023–20240 recalls

FDA records 2 decisions for Medency S.R.L. (Vicenza, IT) from 2023 to 2024: 2 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NVK (Laser, Dental, Soft Tissue). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Medency S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Medency S.R.L. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision
  • NVKLaser, Dental, Soft Tissue1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K240543Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Medency S.R.L. · 2024
  • K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L. · 2023

All 2 as Medency S.R.L. →