FDA applicant

American Surgical Laser, Inc.

Mchenry, IL5 decisions1984–19850 recalls

FDA records 5 decisions for American Surgical Laser, Inc. (Mchenry, IL) from 1984 to 1985: 5 510(k) clearances. Most are in product codes GEY (Motor, Surgical Instrument, Ac-Powered) and EWG (Laser, Ent Microsurgical Carbon-Dioxide). 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 Surgical Laser, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Surgical Laser, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like American Surgical Laser, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

American Surgical Laser, Inc.

Which product codes does it file in?

What has FDA decided for it lately?