The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Xen Glaucoma Treatment System.
| Device ID | K161457 |
| 510k Number | K161457 |
| Device Name: | XEN Glaucoma Treatment System |
| Classification | Implant, Eye Valve |
| Applicant | Allergan, Inc. 26970 Aliso Viejo Parkway, Suite 200 Aliso Viejo, CA 92656 |
| Contact | Barbara A. Niksch |
| Correspondent | Barbara A. Niksch Allergan, Inc. 2525 Dupont Drive Mail Code T2-6L Irvine, CA 92612 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-26 |
| Decision Date | 2016-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888628032439 | K161457 | 000 |