K161457 is an FDA 510(k) clearance for the XEN Glaucoma Treatment System. This device is classified as a Implant, Eye Valve (Class II - Special Controls, product code KYF).
Submitted by Allergan, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 21, 2016, 179 days after receiving the submission on May 26, 2016.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3920.
| 510(k) Number | K161457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2016 |
| Decision Date | November 21, 2016 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYF - Implant, Eye Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3920 |