FDA applicant

Directed Energy, Inc.

Los Angeles, CA39 decisions1984–19910 recalls

FDA records 39 decisions for Directed Energy, Inc. (Los Angeles, CA) from 1984 to 1991: 39 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) 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 Directed Energy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Directed Energy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Directed Energy, 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

Other applicant names beginning “Directed”

FDA records each applicant name separately; these may or may not be the same firm.

Directed Systems, Ltd. 2

Directed Energy, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Directed”