Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lumenis — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
239 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100415 | ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LAS | Lumenis | 2010-04-21 | 64 | 1 |
| K030527 | LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS | Lumenis | 2003-05-20 | 90 | 0 |
| K020591 | BCLEAR | Lumenis | 2002-05-16 | 83 | 0 |
| K011197 | DERMACLEAR UV-B PHOTOTHERAPY SYSTEM | Lumenis | 2001-12-14 | 239 | 0 |
| K011703 | LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVE | Lumenis | 2001-08-29 | 89 | 2 |
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