510(k) Report

FDA applicant

Emoled, Srl

Sesto Fiorentino, IT1 decision2024–20240 recalls

FDA records 1 decision for Emoled, Srl (Sesto Fiorentino, IT) in 2024: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 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 Emoled, Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Emoled, Srl by year, 2024–2026Sources: 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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K240132EmoLED (v. 2-USA)Emoled, Srl · 2024

The one decision as Emoled, Srl →