FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WHITE OCULAR PRESSURE RELIEF DEVICE
K Number: K840204
·
Decision Feb 15, 1985
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
24
Applicant Total
4
Review Days
393
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WHITE OCULAR PRESSURE RELIEF DEVICE
- K Number
- K840204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3920
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Precision-Cosmet Co., Inc.
- Date Received
- January 19, 1984
- Decision Date
- February 15, 1985
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYF), ordered by most recent decision date.
Ahmed® Glaucoma Valve Model FP7
FDA 510(k)
FDA Class 2
·Ophthalmic
Ahmed® Glaucoma Valve Model FP8
FDA 510(k)
FDA Class 2
·Ophthalmic
iStent infinite Trabecular Micro-Bypass System, Model iS3
FDA 510(k)
FDA Class 2
·Ophthalmic
AHMED ClearPath Glaucoma Drainage Device
FDA 510(k)
FDA Class 2
·Ophthalmic
Ahmed Glaucoma Valve Model FP8
FDA 510(k)
FDA Class 2
·Ophthalmic
XEN Glaucoma Treatment System
FDA 510(k)
FDA Class 2
·Ophthalmic