Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Venus Concept , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
272 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162765 | Venus Velocity Diode Laser System | Venus Concept , Ltd. | 2017-01-11 | 103 | 0 |
| K153717 | Venus Versa System | Venus Concept , Ltd. | 2016-03-21 | 88 | 0 |
| K152790 | Venus Versa System | Venus Concept , Ltd. | 2016-01-20 | 117 | 0 |
| K143554 | Venus Legacy CX | Venus Concept , Ltd. | 2015-08-04 | 232 | 0 |
| K150161 | Venus Viva SR Device | Venus Concept , Ltd. | 2015-05-12 | 109 | 0 |
| K140629 | VENUS SWAN(MP)2 | Venus Concept , Ltd. | 2014-06-25 | 106 | 0 |
| K111670 | VENUS FREEZE (MP)2 SYSTEM | Venus Concept , Ltd. | 2012-03-02 | 261 | 0 |
| K111784 | VENUS SWAN SYSTEM | Venus Concept , Ltd. | 2011-10-07 | 108 | 0 |
| K100586 | VENUS FREEZE SYSTEM | Venus Concept , Ltd. | 2010-11-29 | 272 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda