Submission Details
| 510(k) Number | K033701 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 2003 |
| Decision Date | December 15, 2003 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
Dec 2003
Decision
20d
Days
Class 2
Risk
About This 510(k) Submission
K033701 is an FDA 510(k) clearance for the FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES, a Lens, Contact, (disposable) (Class II — Special Controls, product code MVN), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on December 15, 2003, 20 days after receiving the submission on November 25, 2003. 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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