510(k) Report

FDA applicant

Lambda S.P.A.

Brendola, Vicenza, IT1 decision2010–20100 recalls

FDA records 1 decision for Lambda S.P.A. (Brendola, Vicenza, IT) in 2010: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 11 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 Lambda S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Lambda S.P.A. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lambda 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.

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 20101cites it

What has FDA decided for it lately?

  • K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010

The one decision as Lambda S.P.A. →

Other applicant names beginning “Lambda”

FDA records each applicant name separately; these may or may not be the same firm.

Lambda Scientific Spa 1