FDA applicant

Laax, Inc.

Orinda, CA2 decisions2010–20112 recalls

FDA records 2 decisions for Laax, Inc. (Orinda, CA) from 2010 to 2011: 2 510(k) clearances. All are in product code GDW (Staple, Implantable). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

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 Laax, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2015

2010high 2 (2015) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Laax, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Laax, 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?

What has been recalled?