Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lasering S.R.L. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110984 | SLIM E30 II CO2 LASER | Lasering S.R.L. | 2011-07-22 | 106 | 0 |
| K063001 | SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCE | Lasering S.R.L. | 2007-03-07 | 156 | 0 |
| K063396 | VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIE | Lasering S.R.L. | 2007-01-17 | 69 | 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