FDA applicant

Wolff System Technology Corp.

Carlstadt, NJ2 decisions1987–20150 recalls

FDA records 2 decisions for Wolff System Technology Corp. (Carlstadt, NJ) from 1987 to 2015: 2 510(k) clearances. All are in product code LEJ (Booth, Sun Tan). 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 Wolff System Technology Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Wolff”

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

Wolff System GmbH 1

Wolff System Technology Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Wolff”