Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bausch+Lomb — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
196 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170052 | Stellaris Elite vision enhancement system | Bausch+Lomb | 2017-04-19 | 104 | 0 |
| K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | 2017-03-24 | 214 | 0 |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Bausch & Lomb | 2014-03-12 | 119 | 3 |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | Bausch & Lomb | 2014-02-14 | 116 | 0 |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | Bausch & Lomb | 2014-01-09 | 196 | 0 |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | Bausch & Lomb | 2014-01-03 | 78 | 0 |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Bausch & Lomb | 2013-12-27 | 141 | 0 |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-09-17 | 29 | 0 |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-05-16 | 162 | 0 |
| K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TI | Bausch & Lomb | 2006-06-22 | 57 | 0 |
| K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Bausch & Lomb | 2004-07-23 | 106 | 0 |
| K020927 | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINT | Bausch & Lomb | 2002-05-16 | 56 | 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