K083812 is an FDA 510(k) clearance for the REFRESH OPTIVE LENS COMFORT REWETTING DROPS. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Allergan, Inc. (Wilmington, US). The FDA issued a Cleared decision on July 9, 2009, 199 days after receiving the submission on December 22, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K083812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2008 |
| Decision Date | July 09, 2009 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPN - Accessories, Soft Lens Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |