Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lumenis Be, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
272 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 | 186 | 0 |
| K250809 | Stellar M22 | Lumenis Be, Ltd. | 2025-04-16 | 30 | 0 |
| K242349 | FoLix | Lumenis Be, Ltd. | 2024-09-09 | 32 | 0 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and Acce | Lumenis Be, Ltd. | 2023-12-01 | 63 | 0 |
| K222790 | F65 Laser System | Lumenis Be, Ltd. | 2023-06-14 | 272 | 0 |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, | Lumenis Be, Ltd. | 2022-05-18 | 90 | 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