510(k) Report

FDA applicant

Sportarredo Group S.C.

Gruaro, IT2 decisions2016–20170 recalls

FDA records 2 decisions for Sportarredo Group S.C. (Gruaro, IT) from 2016 to 2017: 2 510(k) clearances. All are in product code LEJ (Booth, Sun Tan). Its devices cite 1 predicate, 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 Sportarredo Group S.C.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Sportarredo Group S.C. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LEJBooth, Sun Tan2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152233BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxSportarredo Group S.C. · 20161cites it

What has FDA decided for it lately?

  • K161394HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxSportarredo Group S.C. · 2017
  • K152233BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxSportarredo Group S.C. · 2016

All 2 as Sportarredo Group S.C. →