Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lombart Lenses, Ltd. · 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) |
|---|---|---|---|---|---|
| K971647 | LL BI-FOCAL, DAILY WEAR CONTACT LENS | Lombart Lenses, Ltd. | 1997-07-15 | 71 | 0 |
| K961428 | SOFT-55 DAILY WEAR CONTACT LENS | Lombart Lenses, Ltd. | 1996-05-21 | 36 | 0 |
| K941877 | LL-55 (METHAFILCON A) FOR DAILY WEAR | Lombart Lenses, Ltd. | 1994-06-14 | 57 | 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