Submission Details
| 510(k) Number | K050065 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 12, 2005 |
| Decision Date | May 27, 2005 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
May 2005
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K050065 is an FDA 510(k) clearance for the FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES, 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 May 27, 2005, 135 days after receiving the submission on January 12, 2005. 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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