510(k) Report

FDA applicant

El.En Electronic Engineering Spa

Calenzano, IT27 decisions2007–20230 recalls

FDA records 27 decisions for El.En Electronic Engineering Spa (Calenzano, IT) from 2007 to 2023: 27 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NVK (Laser, Dental, Soft Tissue). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 13 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 Electronic Engineering Spa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007: 22009: 22011: 22013: 32015: 12017: 32018: 42019: 12020: 12021: 62022: 12023: 1
2007high 6 (2021) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — El.En Electronic Engineering Spa by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like El.En Electronic Engineering Spa’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 Instrument21decisions
  • NVKLaser, Dental, Soft Tissue2decisions
  • PBXMassager, Vacuum, Radio Frequency Induced Heat1decision
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision
  • ILYLamp, Infrared, Therapeutic Heating1decision
  • IPFStimulator, Muscle, Powered1decision

How long do its 510(k) reviews take?

Since 2016, its 17 510(k)s took a median of 105 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; 5 of its 17 were faster than that.

Whose devices does it build on?

Its devices cite 37 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 36 times; 13 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.

  • K072159Smart CO2 (Smartxide, Smart US20D) with Dot ScannerEl.En Electronic Engineering Spa · 20076cite it
  • K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa · 20156cite it
  • K192539Deka LuxeaEl.En Electronic Engineering Spa · 20194cite it
  • K181510Echolaser X4El.En Electronic Engineering Spa · 20182cite it
  • K103288Deka Synchro FTEl.En Electronic Engineering Spa · 20112cite it
  • K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa · 20132cite it

What has FDA decided for it lately?

  • K222221Deka HelixEl.En Electronic Engineering Spa · 2023
  • K213658Deka SmartperioEl.En Electronic Engineering Spa · 2022
  • K212270DEKA LipoAIEl.En Electronic Engineering Spa · 2021
  • K211091Deka Tiac IIEl.En Electronic Engineering Spa · 2021
  • K211362SCAR 3El.En Electronic Engineering Spa · 2021
  • K203396Deka SmartperioEl.En Electronic Engineering Spa · 2021
  • K211821DEKA Motus AZEl.En Electronic Engineering Spa · 2021
  • K202258ERISE Laser handpieceEl.En Electronic Engineering Spa · 2021

All 27 as El.En Electronic Engineering Spa →