Submission Details
| 510(k) Number | K050213 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 31, 2005 |
| Decision Date | March 28, 2005 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
FRESHLOOK ONE-DAY COLOR CONTACT LENS
Mar 2005
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K050213 is an FDA 510(k) clearance for the FRESHLOOK ONE-DAY COLOR CONTACT LENS, 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 March 28, 2005, 56 days after receiving the submission on January 31, 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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