FDA applicant

Edge Systems Corp.

Laguna Niguel, CA3 decisions1999–20080 recalls

FDA records 3 decisions for Edge Systems Corp. (Laguna Niguel, CA) from 1999 to 2008: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ILY (Lamp, Infrared, Therapeutic Heating). No recall is linked to its devices.

FDA’s records also spell it “Edge Systems Corporation”, “Edge Systems, Inc.”.

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 Edge Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Edge Systems Corp.’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 “Edge”

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

Edge Medical, LLC 1 Edge Medical Devices, Ltd. 1 Edge Biologicals, Inc. 1

Edge Systems Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Edge”