Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genesis Biosystems, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172714 | LipiVage | Genesis Biosystems, Inc. | 2017-12-08 | 91 | 0 |
| K131142 | GENESIS LED WANDS | Genesis Biosystems, Inc. | 2013-11-27 | 218 | 0 |
| K082484 | ACCELAWAVE SYSTEM | Genesis Biosystems, Inc. | 2008-09-12 | 15 | 0 |
| K081578 | ACCELA SYSTEM | Genesis Biosystems, Inc. | 2008-06-20 | 15 | 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