K051900 is an FDA 510(k) clearance for the ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR. This device is classified as a Lens, Contact, (disposable) (Class II - Special Controls, product code MVN).
Submitted by Johnson & Johnson Vision Care, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 12, 2005, 30 days after receiving the submission on July 13, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K051900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2005 |
| Decision Date | August 12, 2005 |
| Days to Decision | 30 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 |