510(k) Report

FDA applicant

Fisma, Inc.

Salt Lake City, UT4 decisions1996–20000 recalls

FDA records 4 decisions for Fisma, Inc. (Salt Lake City, UT) from 1996 to 2000: 4 510(k) clearances. 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 Fisma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fisma, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fisma, Inc. 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 Instrument4decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K990174Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IVFisma, Inc. · 19993cite it

What has FDA decided for it lately?

  • K000158Veinlase, Model E50-K8-B5, Spectrum K8, Model E50-K8-B9Fisma, Inc. · 2000
  • K991464Dental 200, Dental 300, Dental 400, Models E-20, E-60, E-50Fisma, Inc. · 1999
  • K990174Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IVFisma, Inc. · 1999
  • K963124PC Laser with Smart Plug (PC Edo & Dental 200)Fisma, Inc. · 1996

All 4 as Fisma, Inc. →