510(k) Report

FDA applicant

Intermedic Arfran, SA

Meza, AZ2 decisions2006–20090 recalls

FDA records 2 decisions for Intermedic Arfran, SA (Meza, AZ) from 2006 to 2009: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 17 predicates, 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 Intermedic Arfran, SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intermedic Arfran, SA 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 Instrument2decisions

Whose devices does it build on?

Its devices cite 17 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 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.

  • K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to…Intermedic Arfran, SA · 20068cite it

What has FDA decided for it lately?

  • K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA · 2009
  • K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to…Intermedic Arfran, SA · 2006

All 2 as Intermedic Arfran, SA →