Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Epilady 2000, LLC — 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) |
|---|---|---|---|---|---|
| K233224 | Epilaser Pro | Epilady 2000, LLC | 2024-01-27 | 121 | 0 |
| K213105 | Epilaser Absolute | Epilady 2000, LLC | 2022-12-13 | 445 | 0 |
| K170970 | Epilaser | Epilady 2000, LLC | 2017-09-01 | 154 | 0 |
| K930859 | ROBI COMBI | Epilady 2000, LLC | 1994-02-28 | 375 | 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