FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XEN Glaucoma Treatment System
K Number: K161457
·
Decision Nov 21, 2016
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
24
Applicant Total
33
Review Days
179
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Basic Information
- Device Name
- XEN Glaucoma Treatment System
- K Number
- K161457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3920
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Allergan, Inc.
- Date Received
- May 26, 2016
- Decision Date
- November 21, 2016
- Product Code
- KYF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KYF | Implant, Eye Valve | FDA class 2 | Ophthalmic |
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Other Clearances by Allergan, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K190674 | REFRESH RELIEVA For CONTACTS | Aug 8, 2019 | Substantially Equivalent |
| K143354 | Natrelle 133 Plus Tissue Expander | Aug 20, 2015 | Substantially Equivalent |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | Jul 9, 2009 | Substantially Equivalent |
| K051852 | SINGLE AMPLIFIER FOR BOTOX | Sep 14, 2005 | Substantially Equivalent |
| K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Feb 20, 2002 | Substantially Equivalent |
| K013479 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Feb 11, 2002 | Substantially Equivalent |
| K003252 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Feb 21, 2001 | Substantially Equivalent |
| K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | Feb 13, 2001 | Substantially Equivalent |
| K003109 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Nov 21, 2000 | Substantially Equivalent |
| K000164 | COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION | Jun 2, 2000 | Substantially Equivalent |