Ocular Pattern Recorder
The Ocular Pattern Recorder (product code PLZ) is a Class 2 ophthalmic prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuation, regulated under 886.1925. It requires 510(k) clearance and is used as a non-implantable monitoring tool. The device is not life-sustaining.
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Basic Information
- Product Code
- PLZ
- Device Class
- FDA class 2
- Regulation Number
- 886.1925
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN140017 | SENSIMED TRIGGERFISH | Mar 04, 2016 | Unknown | Sensimed AG |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.