Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mnlase, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
68 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944630 | MODEL 230-SAS LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-09 | 50 | 0 |
| K944627 | MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-03 | 44 | 0 |
| K944628 | MODEL 220-SS LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-03 | 44 | 0 |
| K944629 | MODEL 230-SAC LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-03 | 44 | 0 |
| K944626 | MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-03 | 44 | 0 |
| K944471 | STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE | Mnlase, Inc. | 1994-11-03 | 55 | 0 |
| K944625 | MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-03 | 44 | 0 |
| K944470 | CURVED ENDOPHOTOCOAGULATOR LASER PROBE | Mnlase, Inc. | 1994-11-03 | 55 | 0 |
| K944624 | MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | 42 | 0 |
| K944472 | CURVD ENDOPHOTOCOGULATOR LASER PROBE | Mnlase, Inc. | 1994-11-01 | 53 | 0 |
| K944621 | MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | 42 | 0 |
| K944282 | LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-01 | 60 | 0 |
| K944631 | MODEL 120-SC LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-01 | 42 | 0 |
| K944622 | MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | 42 | 0 |
| K944632 | MODEL 120-SS LASER DELIVERY PROBE | Mnlase, Inc. | 1994-11-01 | 42 | 0 |
| K944623 | MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Mnlase, Inc. | 1994-11-01 | 42 | 0 |
| K921568 | ORS-100 | Mnlase, Inc. | 1992-06-09 | 68 | 0 |
| K921569 | ORS-200 | Mnlase, Inc. | 1992-06-09 | 68 | 0 |
| K921570 | ORS-300 | Mnlase, Inc. | 1992-06-09 | 68 | 0 |
| K921633 | ORS-2000 SERIES | Mnlase, Inc. | 1992-06-02 | 57 | 0 |
| K915085 | DL100 C02 SURGICAL LASER SYSTEM | Mnlase, Inc. | 1992-02-28 | 108 | 0 |
| K915427 | ORS-1000 | Mnlase, Inc. | 1992-01-07 | 36 | 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