Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Depilase Group , Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
116 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030508 | DEPILASE TRIO LASE LASER SYSTEM | Depilase Group , Ltd. | 2003-05-20 | 90 | 0 |
| K030510 | DEPILASE TWIN YAG LASER SYSTEM | Depilase Group , Ltd. | 2003-05-14 | 84 | 0 |
| K030506 | DEPILASE YAG LASE PLUS LASER SYSTEM | Depilase Group , Ltd. | 2003-05-09 | 79 | 0 |
| K020697 | DEPILASE TWIN YAG LASER SYSTEM | Depilase Group , Ltd. | 2002-04-12 | 39 | 0 |
| K020463 | DEPILASE YAG LASE PLUS LASER SYSTEM | Depilase Group , Ltd. | 2002-02-27 | 15 | 0 |
| K020412 | DEPILASE TWIN LASE LASER SYSTEM | Depilase Group , Ltd. | 2002-02-22 | 15 | 0 |
| K001990 | DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES | Depilase Group , Ltd. | 2000-10-23 | 116 | 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