K160859 is an FDA 510(k) clearance for the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E). This device is classified as a Lens, Contact (orthokeratology) (Class II - Special Controls, product code MUW).
Submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on July 13, 2016, 106 days after receiving the submission on March 29, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K160859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2016 |
| Decision Date | July 13, 2016 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MUW - Lens, Contact (orthokeratology) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |