FDA applicant

Shaser, Inc.

Lexington, MA10 decisions2011–20150 recalls

FDA records 10 decisions for Shaser, Inc. (Lexington, MA) from 2011 to 2015: 10 510(k) clearances. Most are in product codes ONF (Powered Light Based Non-Laser Surgical…) and GEX (Powered Laser Surgical Instrument). Its devices cite 18 predicates, 10 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 Shaser, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2011high 3 (2013) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Shaser, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Shaser, 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?