FDA applicant

American Lasers, Inc.

Alhambra, CA5 decisions1995–20060 recalls

FDA records 5 decisions for American Lasers, Inc. (Alhambra, CA) from 1995 to 2006: 5 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 6 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 American Lasers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Lasers, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Lasers, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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American Lasers, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?