FDA applicant

Venus Concept USA, Inc.

Weston, FL11 decisions2014–20220 recalls

FDA records 11 decisions for Venus Concept USA, Inc. (Weston, FL) from 2014 to 2022: 11 510(k) clearances. Most are in product codes PBX (Massager, Vacuum, Radio Frequency Induced Heat) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 7 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 Venus Concept USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2014high 3 (2019) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Venus Concept USA, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Venus”

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

Venus Concept, Ltd. 11

Venus Concept USA, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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?

Other applicant names beginning “Venus”