K053191 is an FDA 510(k) clearance for the DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS. This device is classified as a Lens, Contact, (disposable) (Class II - Special Controls, product code MVN).
Submitted by Innova Vision, Inc. (Flagstaff, US). The FDA issued a Cleared decision on May 12, 2006, 178 days after receiving the submission on November 15, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K053191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2005 |
| Decision Date | May 12, 2006 |
| Days to Decision | 178 days |
| Submission Type | Special |
| 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 |