510(k) Report

FDA applicant

B.V. Intl. S.A.

Clermont-Ferrand, FR1 decision1996–19960 recalls

FDA records 1 decision for B.V. Intl. S.A. (Clermont-Ferrand, FR) in 1996: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 B.V. Intl. S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for B.V. Intl. S.A. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — B.V. Intl. S.A. 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?

  • GEXPowered Laser Surgical Instrument1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K960867Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag Photocoagulator (Evergreen 532)B.V. Intl. S.A. · 19964cite it

What has FDA decided for it lately?

  • K960867Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag Photocoagulator (Evergreen 532)B.V. Intl. S.A. · 1996

The one decision as B.V. Intl. S.A. →