510(k) Report

FDA applicant

American Laser Medical

Salt Lake City, UT5 decisions1996–19990 recalls

FDA records 5 decisions for American Laser Medical (Salt Lake City, UT) from 1996 to 1999: 5 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 3 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 American Laser Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Laser Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Laser Medical 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 Instrument5decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K970667Nuvo-Lase 660 Laser SystemAmerican Laser Medical · 19972cite it
  • K972561Nuvolase 660 Laser System for OphthalmologyAmerican Laser Medical · 19971cites it

What has FDA decided for it lately?

  • K990780Nuvolase 532 Cutaneous Laser SystemAmerican Laser Medical · 1999
  • K972765Nuvolase 720 System for Ophthalmology LaserAmerican Laser Medical · 1997
  • K972561Nuvolase 660 Laser System for OphthalmologyAmerican Laser Medical · 1997
  • K970667Nuvo-Lase 660 Laser SystemAmerican Laser Medical · 1997
  • K963389Flex-Lase 600 Series Ion Laser SystemAmerican Laser Medical · 1996

All 5 as American Laser Medical →