Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Soflex Contact Lens Industries , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
252 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033655 | SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS | Soflex Contact Lens Industries , Ltd. | 2004-07-30 | 252 | 0 |
| K030842 | ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CO | Soflex Contact Lens Industries , Ltd. | 2003-06-06 | 81 | 0 |
| K020642 | SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) | Soflex Contact Lens Industries , Ltd. | 2002-05-24 | 86 | 0 |
| K013469 | EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT L | Soflex Contact Lens Industries , Ltd. | 2001-11-20 | 33 | 0 |
| K013467 | TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOC | Soflex Contact Lens Industries , Ltd. | 2001-11-20 | 33 | 0 |
| K011256 | TORIC LITE LENS | Soflex Contact Lens Industries , Ltd. | 2001-07-17 | 84 | 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