FDA applicant

Lightscalpel, LLC

Woodinville, WA6 decisions2012–20230 recalls

FDA records 6 decisions for Lightscalpel, LLC (Woodinville, WA) from 2012 to 2023: 6 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 18 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Lightscalpel, 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 Lightscalpel, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Lightscalpel, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Lightscalpel, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?