K172314 is an FDA 510(k) clearance for the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D). This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Art Optical Contact Lens, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 2017, 50 days after receiving the submission on August 1, 2017.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K172314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2017 |
| Decision Date | September 20, 2017 |
| Days to Decision | 50 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 |