Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Synergeyes, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
327 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153714 | SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily | Synergeyes, Inc. | 2016-11-15 | 327 | 0 |
| K160938 | SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) | Synergeyes, Inc. | 2016-08-01 | 119 | 0 |
| K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth | Synergeyes, Inc. | 2014-11-19 | 72 | 0 |
| K113586 | SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTAC | Synergeyes, Inc. | 2012-04-18 | 135 | 0 |
| K083921 | SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTAC | Synergeyes, Inc. | 2009-05-20 | 140 | 0 |
| K081034 | SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, | Synergeyes, Inc. | 2008-05-30 | 49 | 0 |
| K080193 | SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR | Synergeyes, Inc. | 2008-03-05 | 40 | 0 |
| K061120 | SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LE | Synergeyes, Inc. | 2006-06-22 | 62 | 0 |
| K060102 | SYNERGEYES PS HYBRID CONTACT LENS | Synergeyes, Inc. | 2006-03-15 | 61 | 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