510(k) K161457
K161457 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "XEN Glaucoma Treatment System". The FDA issued a decision of Substantially Equivalent on November 21, 2016. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Allergan, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2016
- Date Received
- May 26, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Eye Valve
- Device Class
- Class II
- Regulation Number
- 886.3920
- Review Panel
- OP
- Submission Type