Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alcon Research, Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
222 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161794 | CENTURION Vision System (Active SentryTM) | Alcon Research, Ltd. | 2017-04-14 | 288 | 0 |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, | Alcon Research, Ltd. | 2017-03-22 | 28 | 0 |
| K141065 | CONSTELLATION VISION SYSTEM | Alcon Research, Ltd. | 2014-08-22 | 120 | 6 |
| K121031 | WAVELIGHT FS200 PATIENT INTERFACE 1505 | Alcon Research, Ltd. | 2012-06-21 | 77 | 0 |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MO | Alcon Research, Ltd. | 2012-03-27 | 173 | 1 |
| K110951 | 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMI | Alcon Research, Ltd. | 2011-10-17 | 196 | 1 |
| K110166 | CLEARCUT S SAFETY KNIFE | Alcon Research, Ltd. | 2011-05-20 | 120 | 4 |
| K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | 2011-05-10 | 222 | 0 |
| K101006 | WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 | Alcon Research, Ltd. | 2010-10-21 | 192 | 1 |
| K093305 | ENHANCED ULTRA VIT PROBE | Alcon Research, Ltd. | 2010-04-02 | 162 | 0 |
| K091777 | ALCON ULTRACHOPPER | Alcon Research, Ltd. | 2009-10-20 | 125 | 0 |
| K082845 | INFINITI VISION SYSTEM WITH OZIL IP | Alcon Research, Ltd. | 2009-02-12 | 139 | 0 |
| K062930 | LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM | Alcon Research, Ltd. | 2006-11-08 | 41 | 0 |
| K050729 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | 2005-09-14 | 177 | 1 |
| K003768 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | 2001-01-05 | 30 | 0 |
| K001157 | MONARCH II IOL DELIVERY SYSTEM | Alcon Research, Ltd. | 2000-06-27 | 78 | 1 |
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