510(k) Report

FDA applicant

El.En S.P.A.

Calenzano, IT15 decisions2014–20260 recalls

FDA records 15 decisions for El.En S.P.A. (Calenzano, IT) from 2014 to 2026: 15 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 45 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 22 predicates, 1 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 El.En S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2014: 12023: 42024: 62025: 32026 (partial year): 1
2014high 6 (2024) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — El.En S.P.A. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like El.En S.P.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument9decisions
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning1decision
  • IPFStimulator, Muscle, Powered1decision
  • PBXMassager, Vacuum, Radio Frequency Induced Heat1decision
  • PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use1decision

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 45 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 9 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 22 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K133895Deka Smartxide Laser SystemEl.En S.P.A. · 20143cite it
  • K233090DEKA AGAIN PRO familyEl.En S.P.A. · 20232cite it
  • K233473Deka LotusEl.En S.P.A. · 20241cites it

What has FDA decided for it lately?

  • K260647SpecchioEl.En S.P.A. · 2026
  • K251432OloEl.En S.P.A. · 2025
  • K243683Deka BluebeamEl.En S.P.A. · 2025
  • K250281Deka LotusEl.En S.P.A. · 2025
  • K241459MOTUS PRO FamilyEl.En S.P.A. · 2024
  • K240752Deka ToroEl.En S.P.A. · 2024
  • K233473Deka LotusEl.En S.P.A. · 2024
  • K234057NirvanaEl.En S.P.A. · 2024

All 15 as El.En S.P.A. →