510(k) Report

FDA applicant

Servizi Medico Estetici Italinai Srl.

Casale Monferrato (Al), IT2 decisions1997–19980 recalls

FDA records 2 decisions for Servizi Medico Estetici Italinai Srl. (Casale Monferrato (Al), IT) from 1997 to 1998: 2 510(k) clearances. Most are in product codes LFL (Instrument, Ultrasonic Surgical) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). 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 Servizi Medico Estetici Italinai Srl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Servizi Medico Estetici Italinai Srl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Servizi Medico Estetici Italinai Srl. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LFLInstrument, Ultrasonic Surgical1decision
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K971609SculptureServizi Medico Estetici Italinai Srl. · 19972cite it

What has FDA decided for it lately?

  • K980301IP-16Servizi Medico Estetici Italinai Srl. · 1998
  • K971609SculptureServizi Medico Estetici Italinai Srl. · 1997

All 2 as Servizi Medico Estetici Italinai Srl. →