Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Art Optical Contact Lens, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
166 daysmedian FDA review time
231 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens | Art Optical Contact Lens, Inc. | 2023-09-06 | 166 | 0 |
| K172314 | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafo | Art Optical Contact Lens, Inc. | 2017-09-20 | 50 | 0 |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Con | Art Optical Contact Lens, Inc. | 2015-11-24 | 124 | 0 |
| K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015-01-12 | 117 | 0 |
| K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010-09-14 | 231 | 0 |
| K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOX | Art Optical Contact Lens, Inc. | 2008-07-03 | 190 | 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