FDA applicant

Spectragenics, Inc.

Pleasanton, CA5 decisions2003–20090 recalls

FDA records 5 decisions for Spectragenics, Inc. (Pleasanton, CA) from 2003 to 2009: 5 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 39 predicates, 4 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 Spectragenics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spectragenics, Inc.’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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Spectragenics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?