PLZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ocular Pattern Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1925
- Medical specialty
- Ophthalmic
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| SENSIMED TRIGGERFISH (DEN140017) | Sensimed AG | 2016-03-04 |
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Every clearance here is in the API, with alerts when new ones post.