Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lasermatic, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
253 daysmedian FDA review time
466 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903131 | LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM | Lasermatic, Inc. | 1991-02-19 | 217 | 0 |
| K901638 | MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 | Lasermatic, Inc. | 1990-06-27 | 79 | 0 |
| K893529 | COMBOLASER MODEL 5050 | Lasermatic, Inc. | 1989-06-08 | 31 | 0 |
| K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE | Lasermatic, Inc. | 1988-08-22 | 466 | 0 |
| K871934 | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | Lasermatic, Inc. | 1988-03-25 | 311 | 0 |
| K871932 | MODEL 5050 SURGILASER FOR UROLOGY USE | Lasermatic, Inc. | 1988-03-25 | 311 | 0 |
| K871876 | MODEL 5050 SURGILASER FOR PULMONARY USE | Lasermatic, Inc. | 1988-01-22 | 253 | 0 |
| K871933 | MODEL 5050 SURGILASER FOR NEUROSURGERY USE | Lasermatic, Inc. | 1988-01-22 | 248 | 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