Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unicon Optical Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
230 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241707 | OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LEN | Unicon Optical Co., Ltd. | 2024-07-12 | 29 | 0 |
| K213216 | Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact | Unicon Optical Co., Ltd. | 2022-01-18 | 111 | 0 |
| K191929 | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact L | Unicon Optical Co., Ltd. | 2019-09-17 | 60 | 0 |
| K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydr | Unicon Optical Co., Ltd. | 2019-05-16 | 230 | 0 |
| K141917 | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV | Unicon Optical Co., Ltd. | 2014-10-17 | 94 | 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