FDA applicant
Venus Concept, Ltd.
FDA records 11 decisions for Venus Concept, Ltd. (Sunrise, FL) from 2010 to 2025: 11 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Venus Concept, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Venus Concept, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Venus Concept, Ltd.’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) ReportOther applicant names beginning “Venus”
FDA records each applicant name separately; these may or may not be the same firm.