FDA applicant

Premier Laser Systems, Inc.

Irvine, CA14 decisions1994–19990 recalls

FDA records 14 decisions for Premier Laser Systems, Inc. (Irvine, CA) from 1994 to 1999: 14 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 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 Premier Laser Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Premier Laser Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Premier Laser Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?