K180616 is an FDA 510(k) clearance for the OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Contamac, Ltd. (Saffron Walden, GB). The FDA issued a Cleared decision on April 25, 2018, 48 days after receiving the submission on March 8, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K180616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2018 |
| Decision Date | April 25, 2018 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQD - Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |