K061948 is an FDA 510(k) clearance for the PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS. This device is classified as a Lens, Contact, (disposable) (Class II - Special Controls, product code MVN).
Submitted by CooperVision, Inc. (Norfolk, US). The FDA issued a Cleared decision on November 22, 2006, 135 days after receiving the submission on July 10, 2006.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K061948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2006 |
| Decision Date | November 22, 2006 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MVN — Lens, Contact, (disposable) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |