Submission Details
| 510(k) Number | K061948 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
Nov 2006
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K061948 is an FDA 510(k) clearance for the PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS, 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 review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | MVN — Lens, Contact, (disposable) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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