Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Microlight Corporation of America · 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) |
|---|---|---|---|---|---|
| K080786 | ML830TP | Microlight Corporation of America | 2008-10-03 | 197 | 0 |
| K041364 | ML830 LASER SYSTEM | Microlight Corporation of America | 2004-12-13 | 206 | 0 |
| K010175 | MICROLIGHT 830 LASER SYSTEM | Microlight Corporation of America | 2002-02-06 | 384 | 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